Blue Blockers at Night and Insomnia Symptoms

NCT02698800 | Completed Results DMC

• 1 other identifier: AAAQ6404
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia; Sleep

Outcome Measures

Primary Outcomes (2)

• Pittsburgh Insomnia Rating Scale-65 (PIRS65) Total Score

  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)

  After 7 nights of BB lenses

• Pittsburgh Insomnia Rating Scale-65 (PIRS65) Total Score

  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)

  After 7 nights of clear lenses

Secondary Outcomes (2)

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

  After 7 nights of BB lenses

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

  After 7 nights of clear lenses

Study Arms (2)

Blue blocking (BB)

EXPERIMENTAL

Wearing of BB lenses.

Device: Blue blocking (BB) lenses

Clear

PLACEBO COMPARATOR

Wearing of clear lenses

Device: Clear lenses

Interventions

Blue blocking (BB) lenses DEVICE

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

Blue blocking (BB)

Clear lenses DEVICE

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

Clear

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

• 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.

  PMID: 29101797 DERIVED

• 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.

  PMID: 28760541 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Lenses

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Dr. Ari Shechter, Principal Investigator
• Organization: Columbia University Medical Center

as4874@cumc.columbia.edu

212-342-4487

Study Officials

• Ari Shechter, Ph.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medical Sciences (in Medicine)

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: March 4, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 30, 2019
• Results First Posted: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)