Green Light Effect on Sleep

Not Applicable

• Conditions: Sleep

• Registration Number: NCT04828473
• Lead Sponsor: The Green Light Study Center

Brief Summary

The main goal of this study is to determine whether exposure to a narrow band of green light (NBGL) improved sleep quality in healthy subjects.

This is a within-subject study design that examines NBGL effects on sleep onset, sleep fractures (i.e., how many times per night the subjects wake up), total sleep duration, and sleep quality using high-resolution assessments. To complete the study, each participant will complete a 30-day, daily sleep diary while using white light (i.e., being in regular room light) during the last 2 hours of their waking period. This period will be defined as the baseline/control arm of the study. After completing this phase 1, subjects will receive a lamp designed to emit the narrow band of green light and again be asked to complete a 30-day, daily sleep diary, but this timer while using the NBGL light (i.e., being in what appears green light) during the last 2 hours of their waking period. This period will be defined as the active arm of the study. After completing this phase 2,

Detailed Description

Sleep quality will be assessed using the Consensus sleep diary \[Carney et al., (2012)\] The consensus sleep diary: Standardizing prospective sleep self-monitoring, Sleep Vol.35, No.2, pp.287-302\], the latter of which captures total sleep time, sleep latency, wake after sleep onset, number of awakenings, quality, sleep efficiency, and trouble staying awake.

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-03-27
• Study First Submitted QC: 2021-04-01
• Study First Posted: 2021-04-02
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-15
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Healthy volunteers who wish to improve their sleep quality

Exclusion Criteria

• Subjects diagnosed with sleep disorders and are currently on medications and/or devices that aid their sleep ( eg trazadone as medication, CPAP)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
narrow band green light and sleep	2 months	this primary outcome measures improvement in sleep quality during the month in which subjects used the green light as compared to the month in which they used the regular room light. Sleep quality will be measured by the Consensus Sleep Diary. THe Consensus Sleep Diary requires subjects to answer 8 questions by depicting numbers that represent best their answers. These numbers provide the basis for our ability to quantify the difference between the two light conditions of the study.

Trial Locations

Locations (1)

Green Light Sleep Study Center; 🇺🇸 Boca Raton, Florida, United States