Individually Tailored Lighting System to Improve Sleep in Older Adults

• Sponsor: Rensselaer Polytechnic Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01855126
• Collaborator: University of North Carolina (Other)
• Enrollment: 46
• Location: 1
• Arms: 2
• Duration (Months): 49
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

In conjunction with investigators at the Cecil G. Sheps Center for Health Services Research, University of North Carolina (UNC) at Chapel Hill, we propose to develop and evaluate a low-cost, minimally obtrusive device that delivers individualized light therapy to adults with early-awakening insomnia - the most common sleep disturbance in older adults, and a significant problem because of its relationship to daytime sleepiness, use of potentially hazardous sleep medication, and reduced quality of life. The proposed device will measure light/dark exposure data over 24 hours, estimate optimum timing for light delivery, and deliver an individualized light dosage while subjects are asleep. Light applied through closed eyelids in the early part of the night will delay the dim light melatonin onset, a marker of the circadian clock, and help those with early sleep onset to fall asleep later

Condition or Disease	Intervention/Treatment	Phase
Sleep Disturbances	Other: Blue light; Other: Red light	N/A

Detailed Description

We will recruit 50 subjects who report going to bed early and desiring later bedtimes and will ask them to wear an active and an inactive light mask for 8 consecutive weeks each. A 2-week washout period between active and inactive conditions will be applied. Outcome measures will be collected periodically throughout the 8 weeks. Baseline (no intervention) will be collected prior to the active and inactive lighting interventions.

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Enrolled participants will be randomized to receive either the active intervention or placebo intervention and then crossed over to receive the opposite intervention. The study consisted of two intervention periods of 8 weeks separated by a two week washout period.Enrolled participants will be randomized to receive either the active intervention or placebo intervention and then crossed over to receive the opposite intervention. The study consisted of two intervention periods of 8 weeks separated by a two week washout period.
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Individually Tailored Lighting System to Improve Sleep in Older Adults
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Blue light The study protocol consisted of two 8-week intervention/control periods in which each participant wore either the intervention (blue light) or control (red light) mask every night, with the order of presentation of the two conditions randomized by the study's biostatistician. A light mask housing two blue Light Emitting Diodes (LED) arrays delivered a train of blue or red light pulses of 2 second duration that were presented every 30 s for no longer than 2 hr, resulting in a maximum total of approximately 240 pulses per night. the blue light mask was worn nightly for 8 weeks. There will be a two week washout period between each intervention	Other: Blue light; After a two week baseline collection period, half of the subjects will initially be given light masks that deliver blue light through the closed eyelids, while subjects are sleeping. The light mask will always be turned on 120 min before estimated core body temperature minimum (CBTmin); it is expected that blue light exposure will delay the timing of the CBTmin.
Placebo Comparator: Red light The study protocol consisted of two 8-week intervention/control periods in which each participant wore either the intervention (blue light) or control (red light) mask every night, with the order of presentation of the two conditions randomized by the study's biostatistician. A light mask housing two red Light Emitting Diodes (LED) arrays delivered a train of blue or red light pulses of 2 second duration that were presented every 30 s for no longer than 2 hr, resulting in a maximum total of approximately 240 pulses per night. the red light mask was worn nightly for 8 weeks, with a two week washout period between each intervention	Other: Red light; After a two week baseline collection period, half of the subjects will initially be given light masks that deliver red light through the closed eyelids, while subjects are sleeping. The light mask will always be turned on 120 min before estimated core body temperature minimum (CBTmin); it is expected that red light exposure will have no effect on the timing of the CBTmin.

Outcome Measures

Primary Outcome Measures

1. Sleep Disturbance [Baseline (week 0) and week 8 of lighting intervention]

   Pittsburgh Sleep Quality Index. Score range 0 - 21. A score over 5 is indicative of sleep disturbance. Change in score from baseline to intervention is reported. A larger difference indicates a better outcome.

2. Total Sleep Time [baseline week (week 0) and the last week of intervention (week 8)]

   The change in total amount of minutes spent sleeping at night from baseline week to the last week of intervention. A higher number is an improved outcome

3. Sleep Efficiency [baseline week (week 0) and the last week of intervention (week 8)]

   The change in sleep efficiency from baseline to last week of intervention. A higher number is a better outcome. Sleep efficiency is the percentage of time spent in bed sleeping. Scored total sleep time divided by interval duration minus total invalid time (sleep/wake) of the given rest interval multiplied by 100. This data was collected using actigraphy data.

4. Sleep Start Time [baseline week (week 0) and the last week of intervention (week 8)]

   Change in sleep start time, in minutes, from baseline week to the last week of intervention. A higher number is a better outcome. Based on actigraph data

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• age 65 or older

• cognitively capable

• able to respond to study staff verbally and in English

• score greater than 6 using the Pittsburgh Sleepiness Quality Index

• suffer from insomnia

• suffer from excessive daytime sleepiness

Exclusion Criteria:

• Severe sleep apnea

• Severe restless leg syndrome (RLS)

• Significant cognitive impairment

• History of severe photosensitivity dermatitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rensselaer Polytechnic Institute	Troy	New York	United States	12180

Sponsors and Collaborators

• Rensselaer Polytechnic Institute
• University of North Carolina

Investigators

• Principal Investigator: Mariana G Figueiro, PhD, Rensselaer Polytechnic Institute

Study Documents (Full-Text)

• Statistical Analysis Plan - Nov 5, 2018
• Study Protocol - Nov 5, 2018

More Information

Publications

• Figueiro MG, Bierman A, Rea MS. A train of blue light pulses delivered through closed eyelids suppresses melatonin and phase shifts the human circadian system. Nat Sci Sleep. 2013 Oct 4;5:133-41. doi: 10.2147/NSS.S52203. eCollection 2013.
• Figueiro MG, Plitnick B, Rea MS. Pulsing blue light through closed eyelids: effects on acute melatonin suppression and phase shifting of dim light melatonin onset. Nat Sci Sleep. 2014 Dec 2;6:149-56. doi: 10.2147/NSS.S73856. eCollection 2014.

• Responsible Party: Mariana G Figueiro, Professor, Rensselaer Polytechnic Institute
• ClinicalTrials.gov Identifier: NCT01855126
• Other Study ID Numbers: R01AG042602
• First Posted: May 16, 2013
• Last Update Posted: Jan 29, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Mariana G Figueiro, Professor, Rensselaer Polytechnic Institute: light; circadian rhythms; dim light melatonin onset; sleep
• Additional relevant MeSH terms: Dyssomnias; Parasomnias

Study Results

Participant Flow

Pre-assignment Detail	46 participants were enrolled into the study. These participants were randomized to begin the study with the active intervention, or the placebo intervention. After a 2 week washout period, participants were exposed to the opposite intervention.

Arm/Group Title	Active Intervention, Then Placebo	Placebo Intervention, Then Active
Arm/Group Description	Participants started the study wearing the blue mask for 8 weeks. After a 2 week washout period, they wore the red mask for 8 weeks	Participants started the study wearing the red mask every night for 8 weeks. After a 2 week washout period, they wore the blue mask every night for 8 weeks.
Period Title: First Intervention (8 Weeks)
STARTED	24	22
COMPLETED	20	16
NOT COMPLETED	4	6
Period Title: First Intervention (8 Weeks)
STARTED	20	16
COMPLETED	20	16
NOT COMPLETED	0	0
Period Title: First Intervention (8 Weeks)
STARTED	20	16
COMPLETED	18	14
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Active Intervention, Then Placebo Intervention	Placebo Intervention, Then Active Intervention	Total
Arm/Group Description	Participants started the study by wearing the blue mask every night for 8 weeks. After a washout period of 2 weeks, participants wore the red mask every night for 8 weeks	Participants started the study by wearing the red mask every night for 8 weeks. After a washout period of 2 weeks, participants wore the blue mask every night for 8 weeks.	Total of all reporting groups
Overall Participants	24	22	46
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	18 75%	18 81.8%	36 78.3%
>=65 years	6 25%	4 18.2%	10 21.7%
Sex: Female, Male (Count of Participants)
Female	16 66.7%	14 63.6%	30 65.2%
Male	8 33.3%	8 36.4%	16 34.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	7 29.2%	7 31.8%	14 30.4%
White	17 70.8%	15 68.2%	32 69.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	26 108.3%	24 109.1%	50 108.7%
early awakening insomnia (Count of Participants)
Count of Participants [Participants]	24 100%	22 100%	46 100%

Outcome Measures

1. Primary Outcome

Title	Sleep Disturbance
Description	Pittsburgh Sleep Quality Index. Score range 0 - 21. A score over 5 is indicative of sleep disturbance. Change in score from baseline to intervention is reported. A larger difference indicates a better outcome.
Time Frame	Baseline (week 0) and week 8 of lighting intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Blue Light Mask	Red Light Mask
Arm/Group Description	Participants wore the blue mask every night for 8 weeks.	Participants wore the red mask every night for 8 weeks.
Measure Participants	34	34
Mean (Standard Deviation) [units on a scale]	-1.9 (0.5)	-1.3 (0.5)

2. Primary Outcome

Title	Total Sleep Time
Description	The change in total amount of minutes spent sleeping at night from baseline week to the last week of intervention. A higher number is an improved outcome
Time Frame	baseline week (week 0) and the last week of intervention (week 8)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Blue Light Mask	Red Light Mask
Arm/Group Description	Participants started the study wearing the blue light mask every night for 8 weeks.	Participants started the study wearing the red light mask for 8 weeks.
Measure Participants	34	34
Mean (Standard Deviation) [minutes]	4 (22)	1 (19)

3. Primary Outcome

Title	Sleep Efficiency
Description	The change in sleep efficiency from baseline to last week of intervention. A higher number is a better outcome. Sleep efficiency is the percentage of time spent in bed sleeping. Scored total sleep time divided by interval duration minus total invalid time (sleep/wake) of the given rest interval multiplied by 100. This data was collected using actigraphy data.
Time Frame	baseline week (week 0) and the last week of intervention (week 8)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Blue Light Mask	Red Light Mask
Arm/Group Description	Participants started the study wearing the blue mask for 8 weeks.	Participants started the study wearing the red mask every night for 8 weeks.
Measure Participants	34	34
Mean (Standard Deviation) [percentage of sleep]	1.3 (2.9)	-0.6 (4.7)

4. Primary Outcome

Title	Sleep Start Time
Description	Change in sleep start time, in minutes, from baseline week to the last week of intervention. A higher number is a better outcome. Based on actigraph data
Time Frame	baseline week (week 0) and the last week of intervention (week 8)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Blue Light Mask	Red Light Mask
Arm/Group Description	Participants started the study wearing the blue mask for 8 weeks.	Participants started the study wearing the red mask every night for 8 weeks.
Measure Participants	34	34
Mean (Standard Deviation) [minutes]	9 (21)	1 (3)

Adverse Events

Time Frame	20 weeks
Adverse Event Reporting Description	data was collected weekly during each 8 week intervention period
Arm/Group Title	Blue Light		Red Light
Arm/Group Description	This within-subjects, randomized, two-treatment crossover design study consists of two 8-week periods in which each participant wore either the intervention (blue light) or control (red light) mask every night. Subjects will use each condition for eight weeks, with the intervention order counterbalanced across subjects, and a two-week washout period between the two study conditions. The blue mask delivered a flashing blue light for two hours beginning 1 hour after bedtime designed to result in a phase delay of the circadian response curve.		This within-subjects, randomized, two-treatment crossover design study consists of two 8-week periods in which each participant wore either the intervention (blue light) or control (red light) mask every night. Subjects will use each condition for eight weeks, with the intervention order counterbalanced across subjects, and a two-week washout period between the two study conditions. The red mask delivered a flashing red light for two hours beginning 1 hour after bedtime designed to have no effect on the circadian response curve.
All Cause Mortality
	Blue Light		Red Light
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/34 (0%)
Serious Adverse Events
	Blue Light		Red Light
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/34 (0%)
Other (Not Including Serious) Adverse Events
	Blue Light		Red Light
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/34 (38.2%)		12/34 (35.3%)
Eye disorders
Eye Burning	13/34 (38.2%)		12/34 (35.3%)
Eye Redness	10/34 (29.4%)		10/34 (29.4%)
Eye strain	9/34 (26.5%)		8/34 (23.5%)
General disorders
Headache	13/34 (38.2%)		12/34 (35.3%)

Limitations/Caveats

We did not collect circadian marker data (e.g., DLMO) in this field study, it is not known whether any circadian phase shifting resulted. We did not control light during the day which could have counteracted the intervention.

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.