Trial Outcomes & Findings for Individually Tailored Lighting System to Improve Sleep in Older Adults (NCT NCT01855126)
NCT ID: NCT01855126
Last Updated: 2019-01-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
Baseline (week 0) and week 8 of lighting intervention
Results posted on
2019-01-29
Participant Flow
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.
Participant milestones
| Measure |
Active Intervention, Then Placebo
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
|
Placebo Intervention, Then Active
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.
|
|---|---|---|
|
First Intervention (8 Weeks)
STARTED
|
24
|
22
|
|
First Intervention (8 Weeks)
COMPLETED
|
20
|
16
|
|
First Intervention (8 Weeks)
NOT COMPLETED
|
4
|
6
|
|
Washout Period (2 Weeks)
STARTED
|
20
|
16
|
|
Washout Period (2 Weeks)
COMPLETED
|
20
|
16
|
|
Washout Period (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (8 Weeks)
STARTED
|
20
|
16
|
|
Second Intervention (8 Weeks)
COMPLETED
|
18
|
14
|
|
Second Intervention (8 Weeks)
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Active Intervention, Then Placebo
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
|
Placebo Intervention, Then Active
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.
|
|---|---|---|
|
First Intervention (8 Weeks)
Withdrawal by Subject
|
4
|
6
|
|
Second Intervention (8 Weeks)
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Individually Tailored Lighting System to Improve Sleep in Older Adults
Baseline characteristics by cohort
| Measure |
Active Intervention, Then Placebo Intervention
n=24 Participants
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
|
Placebo Intervention, Then Active Intervention
n=22 Participants
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
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
24 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
early awakening insomnia
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 0) and week 8 of lighting interventionPittsburgh 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.
Outcome measures
| Measure |
Blue Light Mask
n=34 Participants
Participants wore the blue mask every night for 8 weeks.
|
Red Light Mask
n=34 Participants
Participants wore the red mask every night for 8 weeks.
|
|---|---|---|
|
Sleep Disturbance
|
-1.9 units on a scale
Standard Deviation 0.5
|
-1.3 units on a scale
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Blue Light Mask
n=34 Participants
Participants wore the blue mask every night for 8 weeks.
|
Red Light Mask
n=34 Participants
Participants wore the red mask every night for 8 weeks.
|
|---|---|---|
|
Total Sleep Time
|
4 minutes
Standard Deviation 22
|
1 minutes
Standard Deviation 19
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Blue Light Mask
n=34 Participants
Participants wore the blue mask every night for 8 weeks.
|
Red Light Mask
n=34 Participants
Participants wore the red mask every night for 8 weeks.
|
|---|---|---|
|
Sleep Efficiency
|
1.3 percentage of sleep
Standard Deviation 2.9
|
-0.6 percentage of sleep
Standard Deviation 4.7
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Blue Light Mask
n=34 Participants
Participants wore the blue mask every night for 8 weeks.
|
Red Light Mask
n=34 Participants
Participants wore the red mask every night for 8 weeks.
|
|---|---|---|
|
Sleep Start Time
|
9 minutes
Standard Deviation 21
|
1 minutes
Standard Deviation 3
|
Adverse Events
Blue Light
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Red Light
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Blue Light
n=34 participants at risk
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.
|
Red Light
n=34 participants at risk
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.
|
|---|---|---|
|
Eye disorders
Eye Burning
|
38.2%
13/34 • 20 weeks
data was collected weekly during each 8 week intervention period
|
35.3%
12/34 • 20 weeks
data was collected weekly during each 8 week intervention period
|
|
Eye disorders
Eye Redness
|
29.4%
10/34 • 20 weeks
data was collected weekly during each 8 week intervention period
|
29.4%
10/34 • 20 weeks
data was collected weekly during each 8 week intervention period
|
|
Eye disorders
Eye strain
|
26.5%
9/34 • 20 weeks
data was collected weekly during each 8 week intervention period
|
23.5%
8/34 • 20 weeks
data was collected weekly during each 8 week intervention period
|
|
General disorders
Headache
|
38.2%
13/34 • 20 weeks
data was collected weekly during each 8 week intervention period
|
35.3%
12/34 • 20 weeks
data was collected weekly during each 8 week intervention period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place