Blue Blockers at Night and Insomnia Symptoms

NCT ID: NCT02698800

Last Updated: 2019-07-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-03-31

Brief Summary

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Under entrained conditions, humans maintain a consolidated nocturnal sleep episode that coincides with environmental darkness and endogenous melatonin secretion. Various factors, such as artificial light, can compromise this temporal harmony, resulting in sleep disruption. Light is the strongest synchronizer of the circadian clock, with direct inputs via the retinohypothalamic tract to brain centers regulating sleep and circadian rhythms. Evening light exposure can suppress melatonin secretion and worsen sleep. This is critical, since most individuals routinely expose themselves to light before bedtime. The high sensitivity of the circadian system to blue wavelength light indicates that modern light sources such as light-emitting diodes (LED) may have particularly deleterious effects on sleep. It is possible to selectively filter out blue light while maintaining other visible spectra with blue-blocking (BB) lenses. Wearing BB lenses before bedtime may present a simple, affordable, and safe method to improve sleep. None have yet investigated the effects of BB lenses on subjective and objective sleep in insomnia patients, while simultaneously exploring the effects on melatonin secretion.

Detailed Description

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This study seeks to investigate the impact of BB lenses on melatonin and sleep in insomnia patients using a randomized, placebo-controlled crossover study, with the aim of developing a novel non-pharmacological approach for the treatment of insomnia. 15 individuals with insomnia will wear either BB or placebo (clear) lenses for 2 hours preceding bedtime while at home, for 1 week in a cross-over design. Sleep quality will be documented while at home, at also melatonin secretion while in the laboratory. It is predicted that compared to placebo, wearing BB lenses for 2 hours preceding bedtime will attenuate bright light associated melatonin suppression and improve sleep.

Conditions

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Insomnia Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Blue blocking (BB)

Wearing of BB lenses.

Group Type EXPERIMENTAL

Blue blocking (BB) lenses

Intervention Type DEVICE

Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime.

Clear

Wearing of clear lenses

Group Type PLACEBO_COMPARATOR

Clear lenses

Intervention Type DEVICE

Participants will wear clear lenses each night for 1 week for 2 hours preceding bedtime.

Interventions

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Blue blocking (BB) lenses

Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime.

Intervention Type DEVICE

Clear lenses

Participants will wear clear lenses each night for 1 week for 2 hours preceding bedtime.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Insomnia for at least 1 month based on Insomnia Symptoms Questionnaire

Exclusion Criteria

* obstructive sleep apnea; narcolepsy; periodic leg movement disorder
* currently shift worker
* psychiatric or neurologic disorders
* deep vein thrombosis
* current cigarette smoker
* currently taking beta-blockers
* pregnant/breastfeeding
* children less than 1 year old at home
* excessive daily caffeine intake
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Ari Shechter

Assistant Professor of Medical Sciences (in Medicine)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ari Shechter, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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Shechter A, Kim EW, St-Onge MP, Westwood AJ. Blocking nocturnal blue light for insomnia: A randomized controlled trial. J Psychiatr Res. 2018 Jan;96:196-202. doi: 10.1016/j.jpsychires.2017.10.015. Epub 2017 Oct 21.

Reference Type DERIVED
PMID: 29101797 (View on PubMed)

Shechter A, Westwood AJ. A behavioral intervention for insomnia improves blood pressure. Sleep Med. 2017 Sep;37:225. doi: 10.1016/j.sleep.2017.07.003. Epub 2017 Jul 15. No abstract available.

Reference Type DERIVED
PMID: 28760541 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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AAAQ6404

Identifier Type: -

Identifier Source: org_study_id

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