Recruiting
Phase 2

Phototherapy

Sponsor:

University of Arizona

Code:

NCT05116358

Conditions

Sleep

Eligibility Criteria

Sex: All

Age: 30 - 60

Healthy Volunteers: Accepted

Interventions

Phototherapy device

Study Details

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.

Conditions

Sleep

Study ID

NCT05116358

Start date

Sep 2, 2021

Status verified date

Nov, 2021

Completion date

Jan 30, 2022

Anticipated

Primary completion date

Jan 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 60

Healthy Volunteers: Accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active

An active phototherapy device

sham comparator: Sham (Placebo)

An inactive device

Interventions

Phototherapy device

The active phototherapy device will emit light

Primary outcome measure

  • 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) ]
  • 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) ]
  • 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. ]

Central Contacts and Locations

Locations

Department of Psychiatry, University of Arizona

Recruiting

Tucson, Arizona, United States, 85719

Contacts

More Information

Sponsor

University of Arizona

Last update posted

Nov 11, 2021

Last verified

Nov, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2021-11-11.