Trial Outcomes & Findings for Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease (NCT NCT03256539)
NCT ID: NCT03256539
Last Updated: 2025-11-14
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Up to 24 weeks following study initiation
Results posted on
2025-11-14
Participant Flow
Participant milestones
| Measure |
Sleep Intervention
An FDA-authorized prescription digital cognitive behavioral therapy for insomnia (CBT-I) therapeutic treatment
|
Placebo Intervention
Placebo (quasi-desensitization) intervention for insomnia (which does not include any of the active components of CBT-I but implements in the same frequency and duration).
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
| Measure |
Sleep Intervention
An FDA-authorized prescription digital cognitive behavioral therapy for insomnia (CBT-I) therapeutic treatment
|
Placebo Intervention
Placebo (quasi-desensitization) intervention for insomnia (which does not include any of the active components of CBT-I but implements in the same frequency and duration).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Unexpected closure of study components
|
8
|
4
|
Baseline Characteristics
Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Sleep Intervention
n=8 Participants
An FDA-authorized prescription digital cognitive behavioral therapy for insomnia (CBT-I) therapeutic treatment
|
Placebo Intervention
n=7 Participants
Placebo (quasi-desensitization) intervention for insomnia (which does not include any of the active components of CBT-I but implements in the same frequency and duration).
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=171 Participants
|
5 Participants
n=23 Participants
|
12 Participants
n=306 Participants
|
|
Age, Continuous
|
75.6 years
STANDARD_DEVIATION 5.15 • n=171 Participants
|
74.1 years
STANDARD_DEVIATION 4.81 • n=23 Participants
|
74.93 years
STANDARD_DEVIATION 4.88 • n=306 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=171 Participants
|
7 Participants
n=23 Participants
|
11 Participants
n=306 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
4 Participants
n=306 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=171 Participants
|
5 Participants
n=23 Participants
|
12 Participants
n=306 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=171 Participants
|
2 Participants
n=23 Participants
|
3 Participants
n=306 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=171 Participants
|
2 Participants
n=23 Participants
|
3 Participants
n=306 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=171 Participants
|
7 participants
n=23 Participants
|
15 participants
n=306 Participants
|
|
Pittsburgh Sleep Quality Index (PSQI)
|
9.88 units on a scale
STANDARD_DEVIATION 3.18 • n=171 Participants
|
11.4 units on a scale
STANDARD_DEVIATION 3.51 • n=23 Participants
|
10.6 units on a scale
STANDARD_DEVIATION 3.31 • n=306 Participants
|
|
Insomnia Severity Index (ISI)
|
16.8 units on a scale
STANDARD_DEVIATION 5.52 • n=171 Participants
|
15.2 units on a scale
STANDARD_DEVIATION 4.90 • n=23 Participants
|
16.03 units on a scale
STANDARD_DEVIATION 5.11 • n=306 Participants
|
|
Quick Dementia Rating System (QDRS) Category
Mild cognitive impairment
|
4 Participants
n=171 Participants
|
4 Participants
n=23 Participants
|
8 Participants
n=306 Participants
|
|
Quick Dementia Rating System (QDRS) Category
Mild dementia
|
4 Participants
n=171 Participants
|
3 Participants
n=23 Participants
|
7 Participants
n=306 Participants
|
|
STOP-BANG sleep apnea scale
High risk
|
1 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=306 Participants
|
|
STOP-BANG sleep apnea scale
Intermediate risk
|
5 Participants
n=171 Participants
|
1 Participants
n=23 Participants
|
6 Participants
n=306 Participants
|
|
STOP-BANG sleep apnea scale
Low risk
|
2 Participants
n=171 Participants
|
6 Participants
n=23 Participants
|
8 Participants
n=306 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeks following study initiationOutcome measures
| Measure |
Sleep Intervention
n=8 Participants
An FDA-authorized prescription digital cognitive behavioral therapy for insomnia (CBT-I) therapeutic treatment
|
Placebo Intervention
n=7 Participants
Placebo (quasi-desensitization) intervention for insomnia (which does not include any of the active components of CBT-I but implements in the same frequency and duration).
|
|---|---|---|
|
Number of Participants Enrolled to the Study
|
8 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Through study completion, up to 34 weeksPopulation: Data were not collected due to study termination prior to participants' assessment at the pre-specified time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 34 weeksPopulation: Data were not collected due to study termination prior to participants' assessment at the pre-specified time points.
Week-long measurement using wrist actigraphy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 34 weeksPopulation: Data were not collected due to study termination prior to participants' assessment at the pre-specified time points.
Outcome measures
Outcome data not reported
Adverse Events
Sleep Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Intervention
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