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Clinical Trials/NCT04828473
NCT04828473
Unknown
Not Applicable

Green Light Effect on Sleep

The Green Light Study Center1 site in 1 country25 target enrollmentOctober 1, 2020
ConditionsSleep

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep
Sponsor
The Green Light Study Center
Enrollment
25
Locations
1
Primary Endpoint
narrow band green light and sleep
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
October 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
The Green Light Study Center
Responsible Party
Principal Investigator
Principal Investigator

Paul Hart

Primary Care Provider

The Green Light Study Center

Eligibility Criteria

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)

Outcomes

Primary Outcomes

narrow band green light and sleep

Time Frame: 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.

Study Sites (1)

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