NCT05616819

Effect of Morning Light Exposure on Mood

Regulating Mood and Suicidal Ideation With Morning Light Exposure Treatment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Mood dysregulation and suicidal ideation are closely associated with disruption of sleep and circadian rhythms. Moreover, sleep problems and circadian disruption are commonplace features of military life. Critically, specifically timed light exposure plays a powerful role in regulating mood, circadian rhythms, and sleep-wake patterns. Therefore, investigators propose to conduct a large-scale clinical trial on the effectiveness of morning light exposure treatment for improving sleep-wake patterns, emotional and mental health, and suicidal thoughts in military personnel.

Detailed description

The objective is to determine the effectiveness of daily morning light therapy for regulating the circadian rhythm to improve mood and reduce suicidal thinking. Our working hypotheses are that daily exposure to the active light for two weeks will 1) lead to a phase advance entrainment of sleep timing relative to a placebo light therapy, 2) lead to improved/sustained mental health outcomes, including suicidal ideation, relative to a placebo light therapy, and that 3) most military Service members will rate the use of a light "headset" device acceptable as a treatment option after their experience. Over a 3-year period of performance, investigators aim to 1) determine the effectiveness of daily morning active light condition therapy for regulating circadian timing and sleep, 2) determine the effectiveness of daily morning active light condition therapy for sustaining or improving mental health outcomes, including suicidal ideation, relative to placebo light therapy, and 3) determine the acceptability and "buy-in" from military personnel using a daily light headset device. During this study, 400 military personnel will complete a double-blind, placebo-controlled, counterbalanced, crossover design study of the effects of 30-minutes of daily morning active light condition therapy versus a placebo light therapy on measured sleep and mental health outcomes. Participants will complete two weeks of morning active light condition therapy with a commercially available headset with four built-in light-emitting diode (LEDs) and internal compliance monitors, and two weeks wearing the same type of glasses fit with placebo light-emitting diode (LEDs), in a counterbalanced order, separated by a two-week washout period. An online assessment battery for mental health and suicidal ideation will be completed before and after each treatment period, and sleep/circadian rhythms will be monitored throughout via continuous actigraphy and daily brief sleep/mood/suicidal ideation logs. It is important to note that investigators also monitored sleep/circadian rhythms via 5-channel at-home EEG recordings for the first few participants who completed the study before investigators removed the use of the EEG recording device from the study protocol due to prohibitive costs associated with using the manufacturer's software.

Conditions

• Suicidal Ideation
• Regulation, Emotion

Interventions

Type	Name	Description
OTHER	Active light exposure	Active light at the wave length of 470nm will be emitted for 30 minutes over a 2 week time frame, from commercially available ayo glasses, as a method to regulated circadian rhythm.
OTHER	Placebo light exposure	Placebo light at the wave length of 578nm will be emitted for 30 minutes over a 2 week time frame, from commercially available ayo glasses, as a control to investigate the regulation of circadian rhythm.

Timeline

• Start date: 2023-07-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2022-11-15
• Last updated: 2025-11-04

Locations

1 site across 1 country: United States