Recruiting

Green Light

Sponsor:

The Green Light Study Center

Code:

NCT04828473

Conditions

Sleep

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

Allay Lamp

Study Details

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

Study ID

NCT04828473

Start date

Oct 1, 2020

Status verified date

Mar, 2022

Completion date

Oct 1, 2022

Anticipated

Primary completion date

Oct 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

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

Enrollment

25 participants

Anticipated

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • narrow band green light and sleep [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

Paul L Hart, MD

561-289-5285plh7275@gmail.com

Locations

Green Light Sleep Study Center

Recruiting

Boca Raton, Florida, United States, 33433

Contacts

Paul L Hart, MD

561-289-5285paulhart46@gmail.com

More Information

Sponsor

The Green Light Study Center

Last update posted

Mar 15, 2022

Last verified

Mar, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Green Light Study Center on 2022-03-15.