Blue Blockers at Night and Insomnia Symptoms

• Sponsor: Columbia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02698800
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia; Sleep	Device: Blue blocking (BB) lenses; Device: Clear lenses	N/A

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.

Study Design

• Study Type: Interventional
• 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: Mar 1, 2016
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Blue blocking (BB) Wearing of BB lenses.	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.

Outcome Measures

Primary Outcome Measures

1. 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)

2. 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 Outcome Measures

1. 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.

2. 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 Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

• Columbia University

Investigators

• Principal Investigator: Ari Shechter, Ph.D., Columbia University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 26, 2018
• Informed Consent Form - Jul 26, 2018

More Information

Publications

None provided.

• Responsible Party: Ari Shechter, Assistant Professor of Medical Sciences (in Medicine), Columbia University
• ClinicalTrials.gov Identifier: NCT02698800
• Other Study ID Numbers: AAAQ6404
• First Posted: Mar 4, 2016
• Last Update Posted: Jul 30, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

Participant Flow

Arm/Group Title	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
Arm/Group Description	Wearing of BB first for 7 days, followed by Clear lenses for 7 days, separated by 4-week washout period Blue blocking (BB) lenses: Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime. Clear lenses: Participants will wear clear lenses each night for 1 week for 2 hours preceding bedtime	Wearing Clear lenses first for 7 days, followed by BB lenses for 7 days, separated by a 4-week washout period
Period Title: Overall Study
STARTED	7	8
COMPLETED	6	8
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Blue Blocking (BB)/Clear
Arm/Group Description	Wearing of BB lenses. Blue blocking (BB) lenses: Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime. Clear lenses: Participants will wear clear lenses each night for 1 week for 2 hours preceding bedtime.
Overall Participants	14
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	14 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.6 (11.5)
Sex: Female, Male (Count of Participants)
Female	8 57.1%
Male	6 42.9%
Race/Ethnicity, Customized (Count of Participants)
Asian	2 14.3%
Black/African American	6 42.9%
White	6 42.9%
Region of Enrollment (participants) [Number]
United States	14 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants who completed both phases

Arm/Group Title	Blue Blocking (BB)
Arm/Group Description	Wearing of BB lenses. Blue blocking (BB) lenses: Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime.
Measure Participants	14
Mean (Standard Deviation) [units on a scale]	72.64 (28.14)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants who complete both phases

Arm/Group Title	Clear
Arm/Group Description	Wearing of clear lenses Clear lenses: Participants will wear clear lenses each night for 1 week for 2 hours preceding bedtime.
Measure Participants	14
Mean (Standard Deviation) [units on a scale]	88.93 (33.19)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants who completed both phases

Arm/Group Title	Blue Blocking (BB)
Arm/Group Description	Wearing of BB lenses. Blue blocking (BB) lenses: Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime.
Measure Participants	14
Mean (Standard Deviation) [% of total sleep time]	78.35 (9)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants who completed both phases

Arm/Group Title	Clear
Arm/Group Description	Wearing of clear lenses Clear lenses: Participants will wear clear lenses each night for 1 week for 2 hours preceding bedtime.
Measure Participants	14
Mean (Standard Deviation) [% of total sleep time]	77.01 (8.67)

Adverse Events

Time Frame	6 weeks
Adverse Event Reporting Description	This was a minimal risk intervention, with no expected adverse events
Arm/Group Title	Blue Blocking (BB)		Clear
Arm/Group Description	Wearing of BB lenses. Blue blocking (BB) lenses: Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime.		Wearing of clear lenses Clear lenses: Participants will wear clear lenses each night for 1 week for 2 hours preceding bedtime.
All Cause Mortality
	Blue Blocking (BB)		Clear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Serious Adverse Events
	Blue Blocking (BB)		Clear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Blue Blocking (BB)		Clear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.