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

  • STATUS
    Recruiting
  • days left to enroll
    4
  • participants needed
    30
  • sponsor
    University of Arizona
Updated on 18 November 2021
Accepts healthy volunteers

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.

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.

Details
Condition Sleep
Treatment Phototherapy device
Clinical Study IdentifierNCT05116358
SponsorUniversity of Arizona
Last Modified on18 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Between the ages of 18 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 >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 moderate to severe 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 12pm 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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