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Green Light Effect on Sleep

NCT04828473 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-03-15

No results posted yet for this study

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

Interventions

DEVICE

Allay Lamp

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.

Sponsors & Collaborators

  • The Green Light Study Center

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-10-01
Completion
2022-10-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04828473 on ClinicalTrials.gov