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