Green Light Effect on Sleep

NCT ID: NCT04828473

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-10-01

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.

Conditions

Sleep

Study Design

• Allocation Method: NA
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Green Light Study Center

OTHER

Sponsor Role: lead

Responsible Party

Paul Hart

Primary Care Provider

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Green Light Sleep Study Center

Boca Raton, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Paul L Hart, MD

Role: CONTACT

plh7275@gmail.com

561-289-5285

Facility Contacts

Paul L Hart, MD

Role: primary

paulhart46@gmail.com

561-289-5285

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id