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

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: Recruiting
• Conditions: Sleep
• Intervention / Treatment: Device: Phototherapy device

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: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • Recruiting
      • Department of Psychiatry, University of Arizona
      • Contact: Michael A Grandner, PhD; Phone Number: 520-626-6246; Email: grandner@email.arizona.edu
      • Contact: Chloe CA Wills; Phone Number: 520 626 1737; Email: chloecawills@psychiatry.arizona.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in subjective rating of the device across a 3-week intervention	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	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	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

Outcome Measure	Measure Description	Time Frame
Change in mean sleep latency assessed using sleep diaries	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	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	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	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	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	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	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	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	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	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	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

• Sponsor: University of Arizona
• Collaborators: CeraZ LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2021
• Primary Completion (Anticipated): January 30, 2022
• Study Completion (Anticipated): January 30, 2022

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 1, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID 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