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Blue Blockers at Night and Insomnia Symptoms

Primary Purpose

Insomnia, Sleep

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blue blocking (BB) lenses
Clear lenses
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Blue blocking (BB)

Clear

Arm Description

Wearing of BB lenses.

Wearing of clear lenses

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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

Full Information

First Posted
February 26, 2016
Last Updated
July 23, 2019
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT02698800
Brief Title
Blue Blockers at Night and Insomnia Symptoms
Official Title
Blocking Nocturnal Blue Light to Treat Insomnia: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blue blocking (BB)
Arm Type
Experimental
Arm Description
Wearing of BB lenses.
Arm Title
Clear
Arm Type
Placebo Comparator
Arm Description
Wearing of clear lenses
Intervention Type
Device
Intervention Name(s)
Blue blocking (BB) lenses
Intervention Description
Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime.
Intervention Type
Device
Intervention Name(s)
Clear lenses
Intervention Description
Participants will wear clear lenses each night for 1 week for 2 hours preceding bedtime.
Primary Outcome Measure Information:
Title
Pittsburgh Insomnia Rating Scale-65 (PIRS65) Total Score
Description
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)
Time Frame
After 7 nights of BB lenses
Title
Pittsburgh Insomnia Rating Scale-65 (PIRS65) Total Score
Description
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)
Time Frame
After 7 nights of clear lenses
Secondary Outcome Measure Information:
Title
Sleep Efficiency (Time Spent Asleep Divided by Total Time in Bed) Determined With Wrist-worn Accelerometry
Description
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.
Time Frame
After 7 nights of BB lenses
Title
Sleep Efficiency (Time Spent Asleep Divided by Total Time in Bed) Determined With Wrist-worn Accelerometry
Description
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.
Time Frame
After 7 nights of clear lenses

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ari Shechter, Ph.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29101797
Citation
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.
Results Reference
derived
PubMed Identifier
28760541
Citation
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.
Results Reference
derived

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Blue Blockers at Night and Insomnia Symptoms

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