Green Light Effect on Sleep

NCT04828473 | Unknown

• 1 other identifier: 001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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,

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

• narrow band green light and sleep

  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.

  2 months

Interventions

Allay Lamp DEVICE

The Allay Lamp is a consumer product currently available and widely used in the US. It emits low intensity (1-10lux)narrow band (20nm) green light (peak wavelength 520nm) that is marketed as non-irritating to users. In that context, it is not a medical device and does not require a 510(k). However, we believe that light likely also has benefits for sleep. To better understand its effects,we are planning to conduct the proposed study. In that context, the Allay Lamp would be considered an investigational medical device because it has not been cleared or approved by FDA for the intended purpose of treating sleep. No FDA submission should be necessary for this study using 21 C.F.R. 812.3, because the Allay Lamp is a non-significant risk (NSR) device: * It is not an implant * It is not intended for use in supporting or sustaining human life The Allay Lamp provides a very low risk light-based therapy. The light provides no more risk than any other table lamp available on the market today.

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers who wish to improve their sleep quality

You may not qualify if:

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

Sponsors & Collaborators

• The Green Light Study Center: lead

Study Sites (1)

Green Light Sleep Study Center

Boca Raton, Florida, 33433, United States

RECRUITING

Central Study Contacts

Paul L Hart, MD

CONTACT

561-289-5285; plh7275@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Care Provider

Model Details: single group assessment

Study Record Dates

• First Submitted: March 27, 2021
• First Posted: April 2, 2021
• Study Start: October 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

US (1)