Clinical trial NCT02698800: Blue Blockers at Night and Insomnia Symptoms
Official title: Blocking Nocturnal Blue Light to Treat Insomnia: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Sleep
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pittsburgh Insomnia Rating Scale-65 (PIRS65) Total Score
timeFrame: After 7 nights of BB lenses
measure: Pittsburgh Insomnia Rating Scale-65 (PIRS65) Total Score
timeFrame: After 7 nights of clear lenses
Secondary outcomes:
measure: Sleep Efficiency (Time Spent Asleep Divided by Total Time in Bed) Determined With Wrist-worn Accelerometry
timeFrame: After 7 nights of BB lenses
measure: Sleep Efficiency (Time Spent Asleep Divided by Total Time in Bed) Determined With Wrist-worn Accelerometry
timeFrame: After 7 nights of clear lenses
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Ari Shechter, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.