NCT05116358

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Sleep

Interventions

Type	Name	Description
DEVICE	Phototherapy device	The active phototherapy device will emit light

Timeline

• Start date: 2021-09-02
• Primary completion: 2022-01-30
• Completion: 2022-01-30
• First posted: 2021-11-11
• Last updated: 2021-11-11

Locations

1 site across 1 country: United States