Phase I/II Study Trial of an Phototherapy Device to Improve Sleep Health
This study involves the use of an light therapy device to test the effects on sleep.
Study phase: Other
Study phase (if other): I/II
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
Inclusion Criteria:
- Between the ages of 30 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 greater than or equal to 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 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 12:00 PM 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
- Not taking any medications or herbals that are intended to promote sleep
- Not taking cold medications that induce sleep
- Alcohol/narcotics consumption
- Not currently using any phototherapy products
Additional information:
The study will take place primarily online, but study visits will take place at the participant's home.
Primary disease category: Sleep Disorders
Secondary disease categories: Healthy Volunteers, Sleep Disorders
Sponsor: Lexington International
Protocol number: Lexington Study
Projected enrollment dates: October 2020 to July 2021
Official study title: Phase I/II Study Trial of an Phototherapy Device to Improve Sleep Health
ClinicalTrials.gov page:
http://www.clinicaltrials.gov/show/Pending