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OpenTrials
Completed

NCT Number: NCT02698800

Blue Blockers at Night and Insomnia Symptoms

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blue blocking (BB) lenses

Device

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

Clear lenses

Device

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

Primary outcomes

  1. Pittsburgh Insomnia Rating Scale-65 (PIRS65) Total Score

    Time frame: After 7 nights of BB lenses

    Pittsburgh Insomnia Rating Scale-65; measures the self-reported severity of insomnia over the past week. Higher scores indicate worsened severity. There are 65 items, each scored on a 4-point scale from low-high on symptom severity or frequency. There is a Total score, and 3 subscales: Distress score (how bothersome the sleep impairment is), Sleep Parameters score (sleep quality), and Quality of Life score.

    For the total score scoring is done by summing the scores from questions 1-65. Minimum Score=0 (good); Maximum Score=195 (bad) For the distress score, scoring is done by summing the scores from questions 1-46. Minimum Score=0 (not bothered); Maximum Score=138 (severely bothered) For the sleep parameters score, scoring is done by summing the scores from questions 47-56. Minimum Score=0 (good sleep); Maximum Score=30 (disrupted sleep) For the quality of life score, scoring is done by summing the scores from questions 57-65. Minimum Score=0 (excellent); Maximum Score=27 (poor)

  2. Pittsburgh Insomnia Rating Scale-65 (PIRS65) Total Score

    Time frame: After 7 nights of clear lenses

    Pittsburgh Insomnia Rating Scale-65; measures the self-reported severity of insomnia over the past week. Higher scores indicate worsened severity. There are 65 items, each scored on a 4-point scale from low-high on symptom severity or frequency. There is a Total score, and 3 subscales: Distress score (how bothersome the sleep impairment is), Sleep Parameters score (sleep quality), and Quality of Life score.

    For the total score scoring is done by summing the scores from questions 1-65. Minimum Score=0 (good); Maximum Score=195 (bad) For the distress score, scoring is done by summing the scores from questions 1-46. Minimum Score=0 (not bothered); Maximum Score=138 (severely bothered) For the sleep parameters score, scoring is done by summing the scores from questions 47-56. Minimum Score=0 (good sleep); Maximum Score=30 (disrupted sleep) For the quality of life score, scoring is done by summing the scores from questions 57-65. Minimum Score=0 (excellent); Maximum Score=27 (poor)

Secondary outcomes

  1. Sleep Efficiency (Time Spent Asleep Divided by Total Time in Bed) Determined With Wrist-worn Accelerometry

    Time frame: After 7 nights of BB lenses

    Wrist-worn accelerometry gives an estimate of time spent asleep, time spent in bed, and sleep efficiency can be calculated from this. Sleep efficiency is calculated as time spent asleep divided by total time in bed. Here, we considered the mean calculated sleep efficiency over each 7-day treatment period.

  2. Sleep Efficiency (Time Spent Asleep Divided by Total Time in Bed) Determined With Wrist-worn Accelerometry

    Time frame: After 7 nights of clear lenses

    Wrist-worn accelerometry gives an estimate of time spent asleep, time spent in bed, and sleep efficiency can be calculated from this. Sleep efficiency is calculated as time spent asleep divided by total time in bed. Here, we considered the mean calculated sleep efficiency over each 7-day treatment period.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Blocking Nocturnal Blue Light to Treat Insomnia: A Pilot Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 4, 2016
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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