Trial Outcomes & Findings for Understanding the Sleep Apnea/Insomnia Interaction (NCT NCT01824472)
NCT ID: NCT01824472
Last Updated: 2020-08-05
Results Overview
Insomnia Severity Index. Minimum: 0. Maximum: 28. Higher scores mean worse outcome. The outcome measure is reported as a change score in which the score at baseline is subtracted from the score at follow-up, thus the more negative the score, the larger the improvement. The total score represents an addition of the questions totals; there is no specific subscale modification required to calculate the total score.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Between Baseline and Day 42.
Results posted on
2020-08-05
Participant Flow
Participant milestones
| Measure |
CPAP+CC
CPAP therapy for sleep apnea and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)
CPAP: Treatment for sleep apnea
CC: Placebo (sham) for insomnia
|
Sham CPAP+CC
sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)
sham CPAP: Placebo for sleep apnea
CC: Placebo (sham) for insomnia
|
CPAP+CBT
CPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia
CPAP: Treatment for sleep apnea
CBT: Treatment for insomnia
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
13
|
15
|
|
Overall Study
COMPLETED
|
16
|
6
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
7
|
4
|
Reasons for withdrawal
| Measure |
CPAP+CC
CPAP therapy for sleep apnea and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)
CPAP: Treatment for sleep apnea
CC: Placebo (sham) for insomnia
|
Sham CPAP+CC
sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)
sham CPAP: Placebo for sleep apnea
CC: Placebo (sham) for insomnia
|
CPAP+CBT
CPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia
CPAP: Treatment for sleep apnea
CBT: Treatment for insomnia
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
3
|
|
Overall Study
Ineligible post randomization&screening
|
0
|
2
|
0
|
Baseline Characteristics
Understanding the Sleep Apnea/Insomnia Interaction
Baseline characteristics by cohort
| Measure |
CPAP+CC
n=17 Participants
CPAP therapy for sleep apnea and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)
CPAP: Treatment for sleep apnea
CC: Placebo (sham) for insomnia
|
Sham CPAP+CC
n=13 Participants
sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)
sham CPAP: Placebo for sleep apnea
CC: Placebo (sham) for insomnia
|
CPAP+CBT
n=15 Participants
CPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia
CPAP: Treatment for sleep apnea
CBT: Treatment for insomnia
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.9 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
49.4 years
STANDARD_DEVIATION 14.6 • n=7 Participants
|
48.5 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
48.2 years
STANDARD_DEVIATION 12.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Insomnia Severity Index
|
22.4 units on a scale
STANDARD_DEVIATION 3.5 • n=5 Participants
|
22.2 units on a scale
STANDARD_DEVIATION 3.1 • n=7 Participants
|
21.4 units on a scale
STANDARD_DEVIATION 3.0 • n=5 Participants
|
21.9 units on a scale
STANDARD_DEVIATION 3.2 • n=4 Participants
|
PRIMARY outcome
Timeframe: Between Baseline and Day 42.Population: Study participants who completed protocol
Insomnia Severity Index. Minimum: 0. Maximum: 28. Higher scores mean worse outcome. The outcome measure is reported as a change score in which the score at baseline is subtracted from the score at follow-up, thus the more negative the score, the larger the improvement. The total score represents an addition of the questions totals; there is no specific subscale modification required to calculate the total score.
Outcome measures
| Measure |
CPAP+CC
n=16 Participants
CPAP therapy for sleep apnea and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)
CPAP: Treatment for sleep apnea
CC: Placebo (sham) for insomnia
|
Sham CPAP+CC
n=6 Participants
sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)
sham CPAP: Placebo for sleep apnea
CC: Placebo (sham) for insomnia
|
CPAP+CBT
n=11 Participants
CPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia
CPAP: Treatment for sleep apnea
CBT: Treatment for insomnia
|
|---|---|---|---|
|
Insomnia Severity Index Score
|
-8.2 score on a scale
Standard Deviation 6.49
|
-7.33 score on a scale
Standard Deviation 7.28
|
-6.27 score on a scale
Standard Deviation 5.9
|
Adverse Events
CPAP+CC
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Sham CPAP+CC
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
CPAP+CBT
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CPAP+CC
n=17 participants at risk
CPAP therapy for sleep apnea and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)
CPAP: Treatment for sleep apnea
CC: Placebo (sham) for insomnia
|
Sham CPAP+CC
n=13 participants at risk
sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)
sham CPAP: Placebo for sleep apnea
CC: Placebo (sham) for insomnia
|
CPAP+CBT
n=15 participants at risk
CPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia
CPAP: Treatment for sleep apnea
CBT: Treatment for insomnia
|
|---|---|---|---|
|
Renal and urinary disorders
Kidney problems
|
0.00%
0/17 • 3 months
We used the clinical trials website definitions
|
7.7%
1/13 • Number of events 1 • 3 months
We used the clinical trials website definitions
|
0.00%
0/15 • 3 months
We used the clinical trials website definitions
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/17 • 3 months
We used the clinical trials website definitions
|
7.7%
1/13 • Number of events 2 • 3 months
We used the clinical trials website definitions
|
0.00%
0/15 • 3 months
We used the clinical trials website definitions
|
Other adverse events
| Measure |
CPAP+CC
n=17 participants at risk
CPAP therapy for sleep apnea and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)
CPAP: Treatment for sleep apnea
CC: Placebo (sham) for insomnia
|
Sham CPAP+CC
n=13 participants at risk
sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)
sham CPAP: Placebo for sleep apnea
CC: Placebo (sham) for insomnia
|
CPAP+CBT
n=15 participants at risk
CPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia
CPAP: Treatment for sleep apnea
CBT: Treatment for insomnia
|
|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/17 • 3 months
We used the clinical trials website definitions
|
7.7%
1/13 • Number of events 1 • 3 months
We used the clinical trials website definitions
|
0.00%
0/15 • 3 months
We used the clinical trials website definitions
|
|
Infections and infestations
Sinus infection
|
5.9%
1/17 • Number of events 1 • 3 months
We used the clinical trials website definitions
|
0.00%
0/13 • 3 months
We used the clinical trials website definitions
|
0.00%
0/15 • 3 months
We used the clinical trials website definitions
|
|
Ear and labyrinth disorders
Ear ache
|
5.9%
1/17 • Number of events 1 • 3 months
We used the clinical trials website definitions
|
0.00%
0/13 • 3 months
We used the clinical trials website definitions
|
0.00%
0/15 • 3 months
We used the clinical trials website definitions
|
|
General disorders
Mouth pain
|
5.9%
1/17 • Number of events 1 • 3 months
We used the clinical trials website definitions
|
0.00%
0/13 • 3 months
We used the clinical trials website definitions
|
0.00%
0/15 • 3 months
We used the clinical trials website definitions
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • 3 months
We used the clinical trials website definitions
|
0.00%
0/13 • 3 months
We used the clinical trials website definitions
|
6.7%
1/15 • Number of events 3 • 3 months
We used the clinical trials website definitions
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.9%
1/17 • Number of events 1 • 3 months
We used the clinical trials website definitions
|
0.00%
0/13 • 3 months
We used the clinical trials website definitions
|
0.00%
0/15 • 3 months
We used the clinical trials website definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place