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

University of Arizona

Status and phase: Unknown; Phase 2

Conditions: Sleep

Treatments: Device: Phototherapy device

Study type: Interventional

Funder types: Other

Identifiers

NCT05116358

2012256803

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups

Active

Active Comparator group

Description:

An active phototherapy device

Treatment:

Device: Phototherapy device

Sham (Placebo)

Sham Comparator group

Description:

An inactive device

Treatment:

Device: Phototherapy device