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

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Phase II Study - Trial of a Phototherapy Light Device to Improve Sleep Health

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Device: Phototherapy device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 18 and 60 years old Able to read and write fluently in English Access to a mobile device for video calls, online questionnaires, syncing devices, and communication with study staff Access to a residential mailing address for shipping study materials Exhibit a score of >8 on the Insomnia Severity Index Self-report that they have a problem with their sleep that they wish to improve Exclusion Criteria: Have a moderate to severe current sleep disorder Have a current psychiatric disorder Are taking medication that would interfere with sleep, including beta blockers, antidepressants, antianxiety medications, hypnotics, or stimulants 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) Exhibit a regular sleep schedule, where bed and wake times are kept within a 2-hour window 7 days per week Exhibit a regular sleep schedule during the night, beginning no earlier than 9pm and ending no later than 10am Have not engaged in shift work for the past month, and will refrain from shift work during the study Are unable to restrict alcohol consumption to no more than 2 drinks within 4 hours of sleep Are unable to restrict caffeine use to no coffee or caffeinated beverages after 12pm during the study Regularly smoke or use other tobacco products Regularly use cannabis-derived medicinal products Are pregnant Are a full-time caregiver to an individual that requires attending during the evening and night

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Phase II Interventional (Clinical Trial) Determine whether use of the light therapy device (versus sham device) results in changes to self-reported sleep quality, self-reported sleep continuity, objectively-estimated sleep continuity, and objectively-estimated sleep architecture. Additionally, to determine whether use of the light therapy device (versus placebo device) results in improvements in mood and daytime functioning .and induce improvements in mood, stress, morning energy levels, perceived daytime functioning, and fatigue levels.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>An active phototherapy device | Device: Phototherapy device<br>* The active phototherapy device will emit light<br>|
| Sham Comparator: Sham (Placebo)<br>An inactive device | Device: Phototherapy device<br>* The active phototherapy device will emit light<br>|

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. |