Trial Outcomes & Findings for Glasses for Adolescent Delayed Sleep-Wake Phase Disorder (NCT NCT04378933)
NCT ID: NCT04378933
Last Updated: 2023-05-06
Results Overview
The time in hours that sleep onset time shifted earlier during school nights. Measured by self-reporting logs and a wrist actigraphy that detects when subjects are active or sleeping.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
baseline, week 3
Results posted on
2023-05-06
Participant Flow
Participant milestones
| Measure |
Amber Glasses and Fixed Wake
Participants wore glasses with amber lenses beginning 7 hours before average baseline mid-sleep time until the time of intended sleep onset or until a duration of 7 hours of use was reached. Participants were also required to wake up at the same time (±30 mins).
Amber Glasses: Half of the participants wore the amber glasses to see if the glasses helped with sleep onset.
|
Clear Glasses and Free Wake
Participants wore identically appearing glasses with clear lenses beginning 7 hours before average baseline mid-sleep time until the time of intended sleep onset or until a duration of 7 hours of use was reached. Participants were given instructions regarding sleep schedule.
Clear Lens Glasses: Half of the participants wore clear glasses to see if the glasses helped with sleep onset.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glasses for Adolescent Delayed Sleep-Wake Phase Disorder
Baseline characteristics by cohort
| Measure |
Amber Glasses and Fixed Wake
n=17 Participants
Participants wore glasses with amber lenses beginning 7 hours before average baseline mid-sleep time until the time of intended sleep onset or until a duration of 7 hours of use was reached. Participants were also required to wake up at the same time (±30 mins).
Amber Glasses: Half of the participants wore the amber glasses to see if the glasses helped with sleep onset.
|
Clear Glasses and Free Wake
n=17 Participants
Participants wore identically appearing glasses with clear lenses beginning 7 hours before average baseline mid-sleep time until the time of intended sleep onset or until a duration of 7 hours of use was reached. Participants were given instructions regarding sleep schedule.
Clear Lens Glasses: Half of the participants wore clear glasses to see if the glasses helped with sleep onset.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.5 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
16.8 years
STANDARD_DEVIATION 1.2 • n=7 Participants
|
16.6 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 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
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, week 3Population: Data not collected nor analyzed for 10 subjects in Amber arm and 9 subjects in Clear arm
The time in hours that sleep onset time shifted earlier during school nights. Measured by self-reporting logs and a wrist actigraphy that detects when subjects are active or sleeping.
Outcome measures
| Measure |
Amber Glasses and Fixed Wake
n=7 Participants
Participants wore glasses with amber lenses beginning 7 hours before average baseline mid-sleep time until the time of intended sleep onset or until a duration of 7 hours of use was reached. Participants were also required to wake up at the same time (±30 mins).
Amber Glasses: Half of the participants wore the amber glasses to see if the glasses helped with sleep onset.
|
Clear Glasses and Free Wake
n=8 Participants
Participants wore identically appearing glasses with clear lenses beginning 7 hours before average baseline mid-sleep time until the time of intended sleep onset or until a duration of 7 hours of use was reached. Participants were given instructions regarding sleep schedule.
Clear Lens Glasses: Half of the participants wore clear glasses to see if the glasses helped with sleep onset.
|
|---|---|---|
|
Change in School Night Sleep Onset Time
|
0.4 hours
Standard Deviation 1.3
|
0.6 hours
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: baseline, week 3Population: Data not collected nor analyzed for 10 subjects in Amber arm and 9 subjects in Clear arm
The time in hours that sleep onset time shifted earlier during non-school nights. Measured by self-reporting logs and a wrist actigraphy that detects when subjects are active or sleeping.
Outcome measures
| Measure |
Amber Glasses and Fixed Wake
n=7 Participants
Participants wore glasses with amber lenses beginning 7 hours before average baseline mid-sleep time until the time of intended sleep onset or until a duration of 7 hours of use was reached. Participants were also required to wake up at the same time (±30 mins).
Amber Glasses: Half of the participants wore the amber glasses to see if the glasses helped with sleep onset.
|
Clear Glasses and Free Wake
n=8 Participants
Participants wore identically appearing glasses with clear lenses beginning 7 hours before average baseline mid-sleep time until the time of intended sleep onset or until a duration of 7 hours of use was reached. Participants were given instructions regarding sleep schedule.
Clear Lens Glasses: Half of the participants wore clear glasses to see if the glasses helped with sleep onset.
|
|---|---|---|
|
Change in Non-school Night Sleep Onset Time
|
1.1 hours
Standard Deviation 1.0
|
0.03 hours
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: baseline, week 3Population: Data not collected nor analyzed for 10 subjects in Amber arm and 9 subjects in Clear arm
The time of day the subject feels sleepy during the overnight lab stays. It is a marker of biological time. Data are provided in decimal and military time (e.g., 10:00 pm equals 22.00). Using a light lux meter, the lighting in the room was limited to no more than 5 lux of light. Measured by self-reported logs and a wrist actigraphy that detects when subjects are active or sleeping.
Outcome measures
| Measure |
Amber Glasses and Fixed Wake
n=7 Participants
Participants wore glasses with amber lenses beginning 7 hours before average baseline mid-sleep time until the time of intended sleep onset or until a duration of 7 hours of use was reached. Participants were also required to wake up at the same time (±30 mins).
Amber Glasses: Half of the participants wore the amber glasses to see if the glasses helped with sleep onset.
|
Clear Glasses and Free Wake
n=8 Participants
Participants wore identically appearing glasses with clear lenses beginning 7 hours before average baseline mid-sleep time until the time of intended sleep onset or until a duration of 7 hours of use was reached. Participants were given instructions regarding sleep schedule.
Clear Lens Glasses: Half of the participants wore clear glasses to see if the glasses helped with sleep onset.
|
|---|---|---|
|
Change in Dim Light Melatonin Onset (DLMO)
baseline
|
21.51 decimal military time
Standard Deviation 1.55
|
22.36 decimal military time
Standard Deviation 2.18
|
|
Change in Dim Light Melatonin Onset (DLMO)
week 3
|
21.11 decimal military time
Standard Deviation 1.12
|
23.05 decimal military time
Standard Deviation 2.17
|
PRIMARY outcome
Timeframe: baseline, week 2Population: Data not collected nor analyzed for 10 subjects in Amber arm and 9 subjects in Clear arm
The time in hours the circadian clock shifted the sleep onset time. Using a light lux meter, the lighting in the room will be limited to no more than 5 lux of light. Measured by self-reported logs and a wrist actigraphy that detects when subjects are active or sleeping.
Outcome measures
| Measure |
Amber Glasses and Fixed Wake
n=7 Participants
Participants wore glasses with amber lenses beginning 7 hours before average baseline mid-sleep time until the time of intended sleep onset or until a duration of 7 hours of use was reached. Participants were also required to wake up at the same time (±30 mins).
Amber Glasses: Half of the participants wore the amber glasses to see if the glasses helped with sleep onset.
|
Clear Glasses and Free Wake
n=8 Participants
Participants wore identically appearing glasses with clear lenses beginning 7 hours before average baseline mid-sleep time until the time of intended sleep onset or until a duration of 7 hours of use was reached. Participants were given instructions regarding sleep schedule.
Clear Lens Glasses: Half of the participants wore clear glasses to see if the glasses helped with sleep onset.
|
|---|---|---|
|
Change in Dim Light Melatonin Onset (DLMO) Phase Shift
|
1.0 hours
Standard Deviation 2.0
|
0.4 hours
Standard Deviation 1.1
|
Adverse Events
Amber Glasses and Fixed Wake
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clear Glasses and Free Wake
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place