Effects of Bright Light on Co-occurring Cancer-related Symptoms in Breast Cancer Survivors

May 22, 2025 updated by: Horng-Shiuann Wu, Michigan State University

Effects of Bright Light on Co-occurring Cancer-related Symptoms in Breast Cancer Survivors: A Personalized Intervention

This study will implement therapeutic bright light that is tailored to the individual's circadian typology and will estimate its effects on circadian rhythms, 4 common cancer-associated symptoms, and impact on quality of life in survivors living with cancer. Examining a selected phase marker (core body temperature) in relation to the associated clinical features (symptoms) is the starting point for future investigation of the biological mechanisms of symptoms.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this pilot study is to evaluate the feasibility of implementing a home-based, personalized bright light intervention, and to estimate the effects of bright light on 4 common long-term or late effects of cancer (sleep disturbance, fatigue, depression, cognitive dysfunction) and on quality of life in post-treatment survivors of breast cancer. The three specific aims include:

Aim #1: To assess the feasibility of implementing a home-based, personalized bright light intervention and the proposed data collection plan in post-treatment survivors of breast cancer.

Aim #2: To estimate the effects of the personalized bright light intervention on sleep disturbance, fatigue, depression, cognitive dysfunction, and quality of life in survivors of breast cancer.

Aim #3: To estimate the effects of a personalized bright light intervention on circadian rhythms in survivors of breast cancer.

The participants of this randomized, controlled pilot study will be randomized to either 30-minute blue-green light therapy at 12,000 lux or dim red light control at 5 lux. Light will be self-administered using a light visor cap at home for 14 consecutive days. Tailored to the individual's circadian pattern, light will be delivered either within 30 minutes of waking in the morning or between 1900-2000 hours in the evening. The nocturnal sleep patterns will be monitored by all-night in-lab polysomnography; sleep quality, fatigue, depression, and quality of life will be self-reported; cognition will be objectively assessed before and after the intervention. Circadian rhythm will be indexed by nocturnal core body temperature before and after the intervention. Feasibility will be determined by the proportion of contacted, recruited, and retained subjects, and completeness of the data collected. Subjective feedback and burden will be assessed at study exit.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Michigan State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Females
  • 21 years of age or older 1-3 years post-completion of chemotherapy or/and radiation therapy for stage I-III breast cancer
  • Experience ≥ 2 concurrent symptoms (fatigue, sleep disruption, depressive symptoms, and/or cognitive dysfunction as measured by 4 screening instruments)
  • Be either phase advanced or delayed (morning or evening types by the Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ) ≥59 or ≤41)
  • Sighted
  • Mentally competent to consent
  • Able to understand English.

Exclusion Criteria:

  • Undergoing cancer treatment for another malignancy
  • Have metastatic cancer
  • Engaged in shift work or travel across more than three time zones within 2 weeks prior to study
  • Current diagnosis of seasonal affective disorder or substance abuse Current diagnosis of major Axis I psychiatric disorders (e.g. depressive disorders), neurological impairments, or muscular dystrophies
  • Report severe depressive mood (Center for Epidemiological Studies Depression Scale (CES-D) >24)
  • Take prescribed sedative hypnotics or steroids Have eye conditions (glaucoma or retinal disease), problems triggered by bright light (e.g., migraine), or take photosensitizing medications (e.g., some porphyrin drugs, antipsychotics, antiarrhythmic agents)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1: Bright blue-green light
  • Bright blue-green light (~515nm; 12,000 lux) for 30 minutes once a day.
  • For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
  • Light therapy will be self-administered using a light visor cap
  • Each participant will make (3) overnight visits to the sleep laboratory
  • On 2 randomly selected days, the participants will wear a light meter during wake time
Diagnostic test: Polysomnography (PSG)
Sleep patterns will be measured by in-lab PSG following a standardized protocol. 10mm silver/silver chloride electroencephalogram (EEG) and electromyography (EMG) electrodes and 11mm silver/silver chloride electroculography (EOG) electrodes will be connected to a Nihon Kohden system, 912 model (Nihon Kohden, Irvine, CA). A standard sleep montage following the 10/20 procedure for electrode placement, left and right electrooculography referenced to the opposite mastoid and mentalis electromyography will be followed. Data will be visually scored by a polysomnographer blind to study conditions following the American Academy of Sleep Medicine (AASM) Manual.
Other Names:
  • PSG
Diagnostic test: Rectal thermistor 400 Series
Nocturnal core body temperature will be measured using a rectal thermistor 400 series manufactured by YSI (Yellow Springs, OH, USA) inserted up to a depth of 7 cm. and taped in place. The thermistor will be connected to a Model 4600 thermometer (YSI, Yellow Springs, OH, USA) that will be interfaced with the PSG via cabling. Core temperature readings will be continuously monitored and recorded every 5 minutes during the all-night sleep studies.
Other: Bright blue-green light
-The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
Diagnostic test: Digital foot candle datalogging light meter
On 2 random days during the 2-week bright light treatment, ambient light will be recorded continuously during waking hours using a digital foot candle datalogging light meter (Extech Instruments, Waltham, MA) Model SDL400. The 7.1" x 2.9" x 1.0" light meter (12.21 oz) has the capacity to measure up to 10,000 footcandles (accuracy: ± 4% reading). The light-weight light sensor is approximately 2 inches in diameter and comes with a clip and strap that makes it comfortable to wear just below the neck.
Other: Pittsburgh Sleep Quality Index (PSQI)
19 self-report items measuring sleep quality, latency, duration, efficiency, disturbance, medication use, and daytime dysfunction. Each item is rated on a 0-3 rating scale. The global PSQI score ranges 0-21, with higher scores indicating more severe sleep disturbance. A global PSQI score greater than 5 was found to have a sensitivity of 89.6% and a specificity of 86.5% in differentiating good and poor sleepers.
Other Names:
  • PSQI
Other: Center for Epidemiological Studies - Depression
20-item self-report instrument commonly used to measure depressive symptoms in cancer patients. Each item is rated on a 4-point rating scale (0=rarely or none of the time to 3=all of the time) describing the frequency of occurrence during the past week. Score can range from 0-60, with higher scores indicating more depressive symptoms.
Other Names:
  • CES-D
Other: Montreal Cognitive Assessment (MoCA)
The MoCA is highly sensitive for screening patient with mild cognitive impairment. The MoCA is a 30-point scale with 7 cognitive subtests: visuo-executive, naming, attention, language, abstraction, delayed recall, and orientation. It scores from 0 to 30, where higher scores indicate better cognition and a score below 26 indicates cognitive impairment. The MoCA is highly sensitive for screening patient with mild cognitive impairment.
Other Names:
  • MoCA
Other: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ-C30)
The EORTC QLQ-C30 consists of 30 items with a 4-point rating scale (1=not at all to 4=very much) measuring functioning, symptom intensity, and global health status/quality of life during the past week.
Other Names:
  • EORTC QLQ-C30
Other: Daily Log
-A log where the participants will indicate date, wake time, sleep time answer 3 questions regarding the previous nights sleep (answers range from 1=not at all to 5=very much), have an area to indicate if naps occurred during the day, and 2 questions about fatigue & sleepiness (answers ranging from 0=no fatigue/sleepiness to 10=worst fatigue/sleepiness
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue

8 items with a 5-point rating scale (1=not at all to 5 =very much) measuring fatigue experience and fatigue impact. Higher scores indicate worse fatigue. PROMIS-Fatigue was developed based on rigorous methodologies. The psychometric properties have been established across chronic illnesses including cancer.

PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population.

Higher scores means more the attribute to be measures: e.g., for fatigue, sleep disturbance, depression, higher scores mean worse fatigue, worse sleep disturbance, worse depression.

But for physical function, higher scores mean better functioning.

Other Names:
  • PROMIS-Cancer-Fatigue
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance

8 items with 5-point rating scales measuring overall sleep and sleep-related impairments. Higher scores indicate worse sleep disturbances. Validity was supported by moderate to high correlations with the existing scales, e.g. PSQI, Epworth Sleepiness Scale (ESS). The scores significantly differed participants with and without sleep disorders.

PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population.

Higher scores means more the attribute to be measures: e.g., for fatigue, sleep disturbance, depression, higher scores mean worse fatigue, worse sleep disturbance, worse depression.

But for physical function, higher scores mean better functioning.

Other Names:
  • PROMIS-Sleep Disturbance
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression

8 items with 5-point rating scales (1=never to 5=always) measuring affective and cognitive manifestations of depressive mood. Higher scores indicate worse depression. In a sample of depressed outpatients, PROMIS-Depression showed greater reliability when compared to the CES-D and the Patient Health Questionnaire (PHQ-9). Convergent validity with the CES-D and PHQ-9 was supported by strong correlations, ranged 0.72 to 0.84

PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population.

Higher scores means more the attribute to be measures: e.g., for fatigue, sleep disturbance, depression, higher scores mean worse fatigue, worse sleep disturbance, worse depression.

But for physical function, higher scores mean better functioning.

Other Names:
  • PROMIS-Depression
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function

8 items with 5-point rating scales measuring the individual's ability to complete daily activities. Higher scores indicate worse functioning. Validity was tested in 1,415 adults with diverse clinical conditions. The PROMIS Physical Function scores corresponded to the expected positive or negative changes in the individual's physical function.

PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population.

Higher scores means more the attribute to be measures: e.g., for fatigue, sleep disturbance, depression, higher scores mean worse fatigue, worse sleep disturbance, worse depression.

But for physical function, higher scores mean better functioning.

Other Names:
  • PROMIS-Physical Function
Active Comparator: Arm 2: Dim red light

  • Dim red light (5 lux) (control group) for 30 minutes once a day.

    --For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.

  • Light therapy will be self-administered using a light visor cap
  • Each participant will make (3) overnight visits to the sleep laboratory --On 2 randomly selected days, the participants will wear a light meter during wake time
Diagnostic test: Polysomnography (PSG)
Sleep patterns will be measured by in-lab PSG following a standardized protocol. 10mm silver/silver chloride electroencephalogram (EEG) and electromyography (EMG) electrodes and 11mm silver/silver chloride electroculography (EOG) electrodes will be connected to a Nihon Kohden system, 912 model (Nihon Kohden, Irvine, CA). A standard sleep montage following the 10/20 procedure for electrode placement, left and right electrooculography referenced to the opposite mastoid and mentalis electromyography will be followed. Data will be visually scored by a polysomnographer blind to study conditions following the American Academy of Sleep Medicine (AASM) Manual.
Other Names:
  • PSG
Diagnostic test: Rectal thermistor 400 Series
Nocturnal core body temperature will be measured using a rectal thermistor 400 series manufactured by YSI (Yellow Springs, OH, USA) inserted up to a depth of 7 cm. and taped in place. The thermistor will be connected to a Model 4600 thermometer (YSI, Yellow Springs, OH, USA) that will be interfaced with the PSG via cabling. Core temperature readings will be continuously monitored and recorded every 5 minutes during the all-night sleep studies.
Diagnostic test: Digital foot candle datalogging light meter
On 2 random days during the 2-week bright light treatment, ambient light will be recorded continuously during waking hours using a digital foot candle datalogging light meter (Extech Instruments, Waltham, MA) Model SDL400. The 7.1" x 2.9" x 1.0" light meter (12.21 oz) has the capacity to measure up to 10,000 footcandles (accuracy: ± 4% reading). The light-weight light sensor is approximately 2 inches in diameter and comes with a clip and strap that makes it comfortable to wear just below the neck.
Other: Pittsburgh Sleep Quality Index (PSQI)
19 self-report items measuring sleep quality, latency, duration, efficiency, disturbance, medication use, and daytime dysfunction. Each item is rated on a 0-3 rating scale. The global PSQI score ranges 0-21, with higher scores indicating more severe sleep disturbance. A global PSQI score greater than 5 was found to have a sensitivity of 89.6% and a specificity of 86.5% in differentiating good and poor sleepers.
Other Names:
  • PSQI
Other: Center for Epidemiological Studies - Depression
20-item self-report instrument commonly used to measure depressive symptoms in cancer patients. Each item is rated on a 4-point rating scale (0=rarely or none of the time to 3=all of the time) describing the frequency of occurrence during the past week. Score can range from 0-60, with higher scores indicating more depressive symptoms.
Other Names:
  • CES-D
Other: Montreal Cognitive Assessment (MoCA)
The MoCA is highly sensitive for screening patient with mild cognitive impairment. The MoCA is a 30-point scale with 7 cognitive subtests: visuo-executive, naming, attention, language, abstraction, delayed recall, and orientation. It scores from 0 to 30, where higher scores indicate better cognition and a score below 26 indicates cognitive impairment. The MoCA is highly sensitive for screening patient with mild cognitive impairment.
Other Names:
  • MoCA
Other: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ-C30)
The EORTC QLQ-C30 consists of 30 items with a 4-point rating scale (1=not at all to 4=very much) measuring functioning, symptom intensity, and global health status/quality of life during the past week.
Other Names:
  • EORTC QLQ-C30
Other: Daily Log
-A log where the participants will indicate date, wake time, sleep time answer 3 questions regarding the previous nights sleep (answers range from 1=not at all to 5=very much), have an area to indicate if naps occurred during the day, and 2 questions about fatigue & sleepiness (answers ranging from 0=no fatigue/sleepiness to 10=worst fatigue/sleepiness
Other: Dim red light
-The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue

8 items with a 5-point rating scale (1=not at all to 5 =very much) measuring fatigue experience and fatigue impact. Higher scores indicate worse fatigue. PROMIS-Fatigue was developed based on rigorous methodologies. The psychometric properties have been established across chronic illnesses including cancer.

PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population.

Higher scores means more the attribute to be measures: e.g., for fatigue, sleep disturbance, depression, higher scores mean worse fatigue, worse sleep disturbance, worse depression.

But for physical function, higher scores mean better functioning.

Other Names:
  • PROMIS-Cancer-Fatigue
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance

8 items with 5-point rating scales measuring overall sleep and sleep-related impairments. Higher scores indicate worse sleep disturbances. Validity was supported by moderate to high correlations with the existing scales, e.g. PSQI, Epworth Sleepiness Scale (ESS). The scores significantly differed participants with and without sleep disorders.

PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population.

Higher scores means more the attribute to be measures: e.g., for fatigue, sleep disturbance, depression, higher scores mean worse fatigue, worse sleep disturbance, worse depression.

But for physical function, higher scores mean better functioning.

Other Names:
  • PROMIS-Sleep Disturbance
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression

8 items with 5-point rating scales (1=never to 5=always) measuring affective and cognitive manifestations of depressive mood. Higher scores indicate worse depression. In a sample of depressed outpatients, PROMIS-Depression showed greater reliability when compared to the CES-D and the Patient Health Questionnaire (PHQ-9). Convergent validity with the CES-D and PHQ-9 was supported by strong correlations, ranged 0.72 to 0.84

PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population.

Higher scores means more the attribute to be measures: e.g., for fatigue, sleep disturbance, depression, higher scores mean worse fatigue, worse sleep disturbance, worse depression.

But for physical function, higher scores mean better functioning.

Other Names:
  • PROMIS-Depression
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function

8 items with 5-point rating scales measuring the individual's ability to complete daily activities. Higher scores indicate worse functioning. Validity was tested in 1,415 adults with diverse clinical conditions. The PROMIS Physical Function scores corresponded to the expected positive or negative changes in the individual's physical function.

PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population.

Higher scores means more the attribute to be measures: e.g., for fatigue, sleep disturbance, depression, higher scores mean worse fatigue, worse sleep disturbance, worse depression.

But for physical function, higher scores mean better functioning.

Other Names:
  • PROMIS-Physical Function

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Study Attrition and Adherence
Time Frame: Up to 3 weeks from registration

Study participants kept a daily log where they listed the dates and times they used the light visor - noting time they put it on, and the time they took it off. The light exposure were recorded to assess adherence to the treatment protocol.

Adherence: percentage that the study participant used the light visor for 30 minutes per day during the 14-day light therapy intervention (based on the daily log that reported use or not use of the light visor for 30 minutes for the 14 days of the intervention and the time they put it on each day and took it off each day)

Attrition: study participants withdrew from the study prior to completing the intervention
Up to 3 weeks from registration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effects of Bright Light on Sleep Disturbance as Measured by the PROMIS-Sleep Disturbance
Time Frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep disturbance T-Score.

A higher PROMIS-Sleep disturbance T-score represents greater\worse sleep disturbance.

PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population.

Higher scores mean worse sleep disturbance

Note: For negatively-worded concepts like Fatigue, a T-score of 60 is one SD worse than average. By comparison, a Fatigue T-score of 40 is one SD better than average.
Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Effects of Bright Light on Sleep Disturbance as Measured by the PSQI
Time Frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

Pittsburgh Sleep Quality Index (PSQI) Global score:

The PSQI has 7 components, with each component self-rated from 0-3, with 3 being worse sleep quality. Global PSQI sleep score is the sum of all 7 components, with score range from 0-21, with higher score meaning worse sleep quality.
Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Effects of Bright Light on Fatigue as Measured by the PROMIS-Cancer-Fatigue
Time Frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue T-Score.

A higher PROMIS-Cancer-Fatigue T-score represents greater\worse fatigue.

PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population.

Higher scores mean worse fatigue

Note: For negatively-worded concepts like Fatigue, a T-score of 60 is one SD worse than average. By comparison, a Fatigue T-score of 40 is one SD better than average.
Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Effects of Bright Light on Fatigue as Measured by the Daily Log
Time Frame: Kept throughout the approx 3 weeks of the study
Fatigue self-report is rated numerically from 1-5, with greater score meaning more fatigue
Kept throughout the approx 3 weeks of the study
Effects of Bright Light on Depression as Measured by the PROMIS-Depression
Time Frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression T-Score.

A higher PROMIS-Depression T-score represents greater\worse Depression.

PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population.

Higher scores mean worse worse depression.

Note: For negatively-worded concepts like Fatigue, a T-score of 60 is one SD worse than average. By comparison, a Fatigue T-score of 40 is one SD better than average.
Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Effects of Bright Light on Depression as Measured by the CES-D
Time Frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

Center for Epidemiologic Studies Depression Scale (CES-D) score:

Total CES-D range is 0-60, with higher score meaning more depressed.
Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Effects of Bright Lights on Cognitive Dysfunction as Measured by the MoCA
Time Frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

MoCA (Montreal Cognitive Assessment):

Test conducted by researcher, with total score range 0-30. Higher score means less cognitive dysfunction.
Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Effect of Bright Light on Quality of Life as Measured by the PROMIS-Physical Function
Time Frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function T-Score.

A higher PROMIS-Physical Function T-score represents greater\better Physical Function.

PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population.

Higher scores mean better functioning.

Note: A T-score of 60 is one SD greater than average; A T-Score of 40 is one SD lower than average.
Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30
Time Frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Quality of Life (QOL)-Global Health score: Range 0-100, higher score is better global health quality of life Quality of Life (QOL) Symptom score: Range 0-100, Higher score is worse symptoms quality of life Quality of Life (QOL)-Function: Range 0-100, Higher score is better functional quality of life
Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Effects of Bright Light on Level of Stress as Measured by the PSG-Total Sleep Time
Time Frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Minutes of total sleep time is reported.
Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Efficiency
Time Frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Objective testing using in-lab polysomnography (PSG)is used to measure the effects of bright light on level of stress. Sleep efficiency is reported as percentage of total sleep time.
Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Onset Latency
Time Frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Minutes of latency to sleep onset is reported.
Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Effects of Bright Light on Level of Stress as Measured by the PSG-Awakenings
Time Frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Objective testing using in-lab polysomnography (PSG)is used to measure the effects of bright light on level of stress. Minutes of awakenings during sleep is recorded.
Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Effects of Bright Light on Level of Stress as Measured by the PSG-Arousals
Time Frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Objective testing using in-lab polysomnography (PSG)is used to measure the effects of bright light on level of stress. Arousal minutes during sleep are recorded
Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Effects of Bright Light on Level of Stress as Measured by the PSG-Arousal Index
Time Frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Arousal index is total number of arousals per hour of sleep.
Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Effects of Bright Light on Level of Stress as Measured by the PSG-Wake After Sleep Onset (WASO)
Time Frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Minutes till wake after sleep onset is reported.
Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min)
Time Frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

Objective testing using in-lab polysomnography (PSG) used to measure effects of bright light on level of stress. Minutes spent in each sleep stage is reported.

Stage 1 is when a person first falls asleep, normally lasts 1-7minutes. Body has not fully relaxed, though body and brain activities start to slow with periods of brief movements.

Stage 2 the body enters a more subdued state including a drop in temperature, relaxed muscles and slowed breathing and heart rate.

Stage 3 muscle tone, pulse and breathing rate decrease as body relaxes. REM brain activity picks up, body experiences atonia-a temporary paralysis of muscles except for eyes and muscles that control breathing. Usually takes 90 minutes to reach REM stage.
Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%)
Time Frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Percentage of time in each sleep stage is reported.

Stage 1 is when a person first falls asleep, normally lasts 1-7minutes. Body has not fully relaxed, though body and brain activities start to slow with periods of brief movements.

Stage 2 the body enters a more subdued state including a drop in temperature, relaxed muscles and slowed breathing and heart rate.

Stage 3 muscle tone, pulse and breathing rate decrease as body relaxes. REM brain activity picks up, body experiences atonia-a temporary paralysis of muscles except for eyes and muscles that control breathing. Usually takes 90 minutes to reach REM stage.
Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Michigan State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Horng-Shiuann Wu, PhD, Michigan State University College of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201703147
  • 1R15NR016828-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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