Phase II Study - Trial of a Phototherapy Light Device to Improve Sleep Health (PHOTONS)

November 1, 2021 updated by: MICHAEL A GRANDNER, University of Arizona
There are few devices currently on the market claiming to improve sleep. This study will investigate the efficacy of phototherapy on improving sleep, in the form of a wearable neck device used at night.

Study Overview

Status

Status

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

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

This study will investigate the efficacy of phototherapy on improving sleep, in the form of a wearable neck device used at night. Phototherapy has been shown to improve chronic pain, cerebral blood flow, neurological function, and capillary growth in skeletal muscle. A device worn at night may improve sleep onset, total sleep time, or modify sleep architecture. Improved cardiovascular function may facilitate a decrease in core body temperature needed for sleep onset. Relaxation from direct heat may help to decrease cortisol levels, thus reducing the number of night-time arousals. It may also decrease circulating levels of norepinephrine (NE), one of the main neurotransmitters involved in arousal. The aim of this study is to evaluate if the device worn leads to greater next-day wellbeing and cognitive function as a result of increased slow-wave activity.

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 (Anticipated)

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.
  • Phase 2

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

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

30 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Between the ages of 18 and 60 years old
  2. Able to read and write fluently in English
  3. Access to a mobile device for video calls, online questionnaires, syncing devices, and communication with study staff
  4. Access to a residential mailing address for shipping study materials
  5. Exhibit a score of >8 on the Insomnia Severity Index
  6. Self-report that they have a problem with their sleep that they wish to improve

Exclusion Criteria:

  1. Have a moderate to severe current sleep disorder
  2. Have a current psychiatric disorder
  3. Are taking medication that would interfere with sleep, including beta blockers, antidepressants, antianxiety medications, hypnotics, or stimulants
  4. Have a medical condition that would interfere with their ability to complete all study procedures or would render measurements invalid (e.g., some autoimmune conditions, cardiac conditions, endocrine conditions, or chronic pain conditions)
  5. Exhibit a regular sleep schedule, where bed and wake times are kept within a 2-hour window 7 days per week
  6. Exhibit a regular sleep schedule during the night, beginning no earlier than 9pm and ending no later than 10am
  7. Have not engaged in shift work for the past month, and will refrain from shift work during the study
  8. Are unable to restrict alcohol consumption to no more than 2 drinks within 4 hours of sleep
  9. Are unable to restrict caffeine use to no coffee or caffeinated beverages after 12pm during the study
  10. Regularly smoke or use other tobacco products
  11. Regularly use cannabis-derived medicinal products
  12. Are pregnant
  13. Are a full-time caregiver to an individual that requires attending during the evening and night

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
Active Comparator: Active
An active phototherapy device
Device: Phototherapy device
The active phototherapy device will emit light
Sham Comparator: Sham (Placebo)
An inactive device
Device: Phototherapy device
The active phototherapy device will emit light

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
Change in subjective rating of the device across a 3-week intervention
Time Frame: Change in subjective rating of the device from baseline (pre; Day 0) to after 21 days of wearing it (post)
There will be a subjective rating of the phototherapy device using a series of questions assessing device's effect on sleep and next-day function at the end of the trial.
Change in subjective rating of the device from baseline (pre; Day 0) to after 21 days of wearing it (post)
Change in Insomnia Severity Index (ISI) scores across a 3-week intervention
Time Frame: Change from baseline over the course of the study (after 21 days of wearing the device)
The ISI is a 7-item insomnia screening tool that is the gold standard for quantifying severity of clinical insomnia symptoms.
Change from baseline over the course of the study (after 21 days of wearing the device)
Change in objective sleep efficiency across a 3-week intervention
Time Frame: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Objective sleep efficiency will be measured with a wearable device (Oura ring) that is worn for the duration of the study and captures sleep and wake data using actigraphy.
Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.

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
Change in mean sleep latency assessed using sleep diaries
Time Frame: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Sleep latency, or time taken to fall asleep, will be assessed using morning sleep diaries completed by the participant upon awakening. The mean sleep latency during the baseline period (pre) will be compared to after three weeks of wearing the phototherapy device (post).
Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Change in Karolinska Sleepiness Scale (KSS) score
Time Frame: Change from before intervention (pre) to post three weeks of wearing the phototherapy device (Day 21)..
The Karolinska Sleepiness Scale (KSS) measures situational sleepiness on a 9-point scale
Change from before intervention (pre) to post three weeks of wearing the phototherapy device (Day 21)..
Circadian Energy Scale (CIRENS) score
Time Frame: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
CIRENS is a very short and simple chronotype measurement tool based on energy. The CIRENS consists of two introspective questions about the usual energy level (very low, low, moderate, high, or very high, scored 1 to 5) in the morning and in the evening. The difference between energy level scores (-4 to 4) felt by respondents in the evening and morning defines the chronotype score and classification.
Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
Positive and Negative Affect Scales (PANAS) Positive Affect
Time Frame: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
The Positive and Negative Affect Scales are brief screening measures that assess both positive and negative emotional experiences. This scale will allow for separate assessment of impact on positive mood.
Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
Positive and Negative Affect Scales (PANAS) Negative Affect
Time Frame: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
The Positive and Negative Affect Scales are brief screening measures that assess both positive and negative emotional experiences. This scale will allow for separate assessment of impact on negative mood.
Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
Change in Fatigue Severity Scale (FSS) across a three-week intervention
Time Frame: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
Fatigue Severity Scale (FSS) is a well-validated 9-item clinical measure that assesses overall levels of mental and physical fatigue, with answers ranging from 1- "Strongly Disagree" to 7-"Strongly Agree".
Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
Change in Profile of Mood States (POMS) across a three week intervention
Time Frame: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
The Profile of Mood States (POMS) is a psychological rating scale used to assess transient, distinct mood states. The POMS measures six different dimensions of mood swings over a period of time. These include: Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment. A total score will be evaluated in addition to the individual items.
Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
Change in Wake After Sleep Onset (WASO) assessed using morning sleep diaries over the duration of the study
Time Frame: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Wake after sleep onset (WASO), or the number of nocturnal awakenings, will be assessed using morning sleep diaries completed by the participant upon awakening. The mean WASO during the baseline period (pre) will be compared to after three weeks of wearing the phototherapy device (post).
Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Change in sleep efficiency assessed using morning sleep diaries over the duration of the study
Time Frame: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Sleep efficiency, or the amount of time spent asleep during a sleep opportunity, will be assessed using morning sleep diaries completed by the participant upon awakening. The mean sleep efficiency during the baseline period (pre) will be compared to after three weeks of wearing the phototherapy device (post).
Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Change in total sleep time assessed using morning sleep diaries over the duration of the study
Time Frame: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Total sleep time will be assessed using morning sleep diaries completed by the participant upon awakening. The mean total sleep time during the baseline period (pre) will be compared to after three weeks of wearing the phototherapy device (post).
Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Change in morning refreshed feeling assessed using morning sleep diaries over the duration of the study
Time Frame: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Morning refreshed feeling will be assessed using morning sleep diaries completed by the participant upon awakening. The mean refreshed feeling during the baseline period (pre) will be compared to after three weeks of wearing the phototherapy device (post).
Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.

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.
University of Arizona

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.
CeraZ LLC

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.
September 2, 2021

Primary Completion (Anticipated)

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.
January 30, 2022

Study Completion (Anticipated)

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.
January 30, 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).
November 1, 2021

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.
November 1, 2021

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.
November 11, 2021

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.
November 11, 2021

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.
November 1, 2021

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.
November 1, 2021

More Information

Terms related to this study

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.
  • 2012256803

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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