Blue Blockers at Night and Insomnia Symptoms
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ClinicalTrials.gov Identifier: NCT02698800 |
Recruitment Status :
Completed
First Posted : March 4, 2016
Results First Posted : July 30, 2019
Last Update Posted : July 30, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Insomnia Sleep | Device: Blue blocking (BB) lenses Device: Clear lenses | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Blocking Nocturnal Blue Light to Treat Insomnia: A Pilot Randomized Controlled Trial |
Actual Study Start Date : | March 2016 |
Actual Primary Completion Date : | March 2017 |
Actual Study Completion Date : | March 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: Blue blocking (BB)
Wearing of BB lenses.
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Device: Blue blocking (BB) lenses
Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime. |
Placebo Comparator: Clear
Wearing of clear lenses
|
Device: Clear lenses
Participants will wear clear lenses each night for 1 week for 2 hours preceding bedtime. |
- 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)
- 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)
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698800
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10032 |
Principal Investigator: | Ari Shechter, Ph.D. | Columbia University |
Documents provided by Ari Shechter, Columbia University:
Responsible Party: | Ari Shechter, Assistant Professor of Medical Sciences (in Medicine), Columbia University |
ClinicalTrials.gov Identifier: | NCT02698800 |
Other Study ID Numbers: |
AAAQ6404 |
First Posted: | March 4, 2016 Key Record Dates |
Results First Posted: | July 30, 2019 |
Last Update Posted: | July 30, 2019 |
Last Verified: | July 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias |
Sleep Wake Disorders Nervous System Diseases Mental Disorders |