Clinical trial NCT05116358: Phase II Study - Trial of a Phototherapy Light Device to Improve Sleep Health
Official title: Phase II Study - Trial of a Phototherapy Light Device to Improve Sleep Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sleep
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: CeraZ LLC
First posted: 2021-11-11
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in subjective rating of the device across a 3-week intervention
timeFrame: Change in subjective rating of the device from baseline (pre; Day 0) to after 21 days of wearing it (post)
measure: Change in Insomnia Severity Index (ISI) scores across a 3-week intervention
timeFrame: Change from baseline over the course of the study (after 21 days of wearing the device)
measure: Change in objective sleep efficiency across a 3-week intervention
timeFrame: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Secondary outcomes:
measure: Change in mean sleep latency assessed using sleep diaries
timeFrame: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
measure: Change in Karolinska Sleepiness Scale (KSS) score
timeFrame: Change from before intervention (pre) to post three weeks of wearing the phototherapy device (Day 21)..
measure: Circadian Energy Scale (CIRENS) score
timeFrame: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
measure: Positive and Negative Affect Scales (PANAS) Positive Affect
timeFrame: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
measure: Positive and Negative Affect Scales (PANAS) Negative Affect
timeFrame: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
measure: Change in Fatigue Severity Scale (FSS) across a three-week intervention
timeFrame: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
measure: Change in Profile of Mood States (POMS) across a three week intervention
timeFrame: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
measure: Change in Wake After Sleep Onset (WASO) assessed using morning sleep diaries over the duration of the study
timeFrame: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
measure: Change in sleep efficiency assessed using morning sleep diaries over the duration of the study
timeFrame: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
measure: Change in total sleep time assessed using morning sleep diaries over the duration of the study
timeFrame: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
measure: Change in morning refreshed feeling assessed using morning sleep diaries over the duration of the study
timeFrame: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Department of Psychiatry, University of Arizona
state: Arizona
Study officials:
References: