Blocking Nocturnal Blue Light to Treat Insomnia: A Pilot Randomized Controlled Trial
| Registry | NCT02698800 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, crossover, masking: single, treatment |
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| Enrollment | 15 (Actual) |
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| Sponsor | Columbia University (Other) |
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| Conditions | Insomnia, Sleep |
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| Interventions | Blue blocking (BB) lenses, Clear lenses (Device) |
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| Dates | start 2016-03-01, primary completion 2017-03-01, completion 2017-03-01, first posted 2016-03-04, last updated 2019-07-30 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Insomnia All trials for Sleep All trials of Blue blocking (BB) lenses All trials of Clear lenses
-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.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Blue blocking (BB) | Experimental | Device: Blue blocking (BB) lenses | Wearing of BB lenses. |
| Clear | Placebo comparator | Device: Clear lenses | Wearing of clear lenses |
- 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.
+Outcome measures
Primary outcomes
- Pittsburgh Insomnia Rating Scale-65 (PIRS65) Total Score [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 [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
- Sleep Efficiency (Time Spent Asleep Divided by Total Time in Bed) Determined With Wrist-worn Accelerometry [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 [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.
+Eligibility
Sex: All, ages: 18 Years to 65 Years, accepts 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
+Posted results
Participant flow
| Milestone | BB First (7 d), Then Clear (7 d), Separated by 4-wk Washout | Clear First (7 ), Then BB (7 d), Separated by 4-wk Washout |
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| Started | 7 | 8 |
| Completed | 6 | 8 |
| Not completed | 1 | 0 |
Outcome results
- Pittsburgh Insomnia Rating Scale-65 (PIRS65) Total Score (Primary), Mean, units on a scale: Blue Blocking (BB) 72.64 +/- 28.14
- Pittsburgh Insomnia Rating Scale-65 (PIRS65) Total Score (Primary), Mean, units on a scale: Clear 88.93 +/- 33.19
- Sleep Efficiency (Time Spent Asleep Divided by Total Time in Bed) Determined With Wrist-worn Accelerometry (Secondary), Mean, % of total sleep time: Blue Blocking (BB) 78.35 +/- 9
- Sleep Efficiency (Time Spent Asleep Divided by Total Time in Bed) Determined With Wrist-worn Accelerometry (Secondary), Mean, % of total sleep time: Clear 77.01 +/- 8.67
Adverse events
Time frame: 6 weeks
| Arm | Deaths | Serious adverse events | Other adverse events |
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| Blue Blocking (BB) | 0/15 (0.0%) | 0/15 (0.0%) | 0/15 (0.0%) |
| Clear | 0/15 (0.0%) | 0/15 (0.0%) | 0/15 (0.0%) |
+Locations (1)
| Facility | City | Country | Status |
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| Columbia University Medical Center | New York, New York | United States | |
+Publications
- Results publication: 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
- Results publication: 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
+Study documents
+Investigators