Trial Outcomes & Findings for Addressing Insufficient PAP Use in Older Veterans (NCT NCT04868682)
NCT ID: NCT04868682
Last Updated: 2025-11-18
Results Overview
Mean hours of PAP use per night calculated for nights 1 to 180 (night 1 is the first night after randomization). Higher numbers indicate a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
Nights 1 to 180 following randomization
Results posted on
2025-11-18
Participant Flow
Participant milestones
| Measure |
PAP Adherence Program
Manual-based program provided by supervised allied health personnel focused on PAP adherence with behavioral strategies to improve PAP adherence and sleep.
|
Active Control
Manual-based general sleep education program provided by supervised allied health personnel.
|
|---|---|---|
|
Post-treatment
STARTED
|
53
|
53
|
|
Post-treatment
COMPLETED
|
51
|
50
|
|
Post-treatment
NOT COMPLETED
|
2
|
3
|
|
Six-month Assessment
STARTED
|
53
|
53
|
|
Six-month Assessment
COMPLETED
|
51
|
52
|
|
Six-month Assessment
NOT COMPLETED
|
2
|
1
|
|
12-month Assessment
STARTED
|
52
|
53
|
|
12-month Assessment
COMPLETED
|
50
|
51
|
|
12-month Assessment
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
PAP Adherence Program
Manual-based program provided by supervised allied health personnel focused on PAP adherence with behavioral strategies to improve PAP adherence and sleep.
|
Active Control
Manual-based general sleep education program provided by supervised allied health personnel.
|
|---|---|---|
|
Post-treatment
Lost to Follow-up
|
1
|
1
|
|
Post-treatment
1 refused assessment; 1 in residing in a nursing home; 1 assessment was missed by staff
|
1
|
2
|
|
Six-month Assessment
Lost to Follow-up
|
1
|
0
|
|
Six-month Assessment
Death
|
1
|
0
|
|
Six-month Assessment
Refused
|
0
|
1
|
|
12-month Assessment
Lost to Follow-up
|
2
|
1
|
|
12-month Assessment
Death
|
0
|
1
|
Baseline Characteristics
Addressing Insufficient PAP Use in Older Veterans
Baseline characteristics by cohort
| Measure |
PAP Adherence Program
n=53 Participants
Manual-based program provided by supervised allied health personnel focused on PAP adherence with behavioral strategies to improve PAP adherence and sleep.
|
Active Control
n=53 Participants
Manual-based general sleep education program provided by supervised allied health personnel.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 9.7 • n=202 Participants
|
65.5 years
STANDARD_DEVIATION 9.1 • n=283 Participants
|
66.3 years
STANDARD_DEVIATION 9.4 • n=120 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=202 Participants
|
5 Participants
n=283 Participants
|
12 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=202 Participants
|
48 Participants
n=283 Participants
|
94 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=202 Participants
|
16 Participants
n=283 Participants
|
25 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=202 Participants
|
37 Participants
n=283 Participants
|
81 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=202 Participants
|
2 Participants
n=283 Participants
|
4 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=202 Participants
|
17 Participants
n=283 Participants
|
38 Participants
n=120 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=202 Participants
|
25 Participants
n=283 Participants
|
47 Participants
n=120 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=202 Participants
|
4 Participants
n=283 Participants
|
8 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=202 Participants
|
4 Participants
n=283 Participants
|
7 Participants
n=120 Participants
|
|
Pittsburgh Sleep Quality Index
|
10.4 units on a scale
STANDARD_DEVIATION 4.5 • n=202 Participants
|
9.9 units on a scale
STANDARD_DEVIATION 4.1 • n=283 Participants
|
10.2 units on a scale
STANDARD_DEVIATION 4.3 • n=120 Participants
|
|
Epworth Sleepiness Scale
|
9.5 units on a scale
STANDARD_DEVIATION 5.4 • n=202 Participants
|
8.3 units on a scale
STANDARD_DEVIATION 4.9 • n=283 Participants
|
8.9 units on a scale
STANDARD_DEVIATION 5.2 • n=120 Participants
|
|
Functional Outcomes of Sleep Questionnaire-10 items
|
14.0 units on a scale
STANDARD_DEVIATION 3.5 • n=202 Participants
|
14.9 units on a scale
STANDARD_DEVIATION 3.7 • n=283 Participants
|
14.4 units on a scale
STANDARD_DEVIATION 3.6 • n=120 Participants
|
PRIMARY outcome
Timeframe: Nights 1 to 180 following randomizationMean hours of PAP use per night calculated for nights 1 to 180 (night 1 is the first night after randomization). Higher numbers indicate a better outcome.
Outcome measures
| Measure |
PAP Adherence Program
n=53 Participants
Manual-based program provided by supervised allied health personnel focused on PAP adherence with behavioral strategies to improve PAP adherence and sleep.
|
Active Control
n=53 Participants
Manual-based general sleep education program provided by supervised allied health personnel.
|
|---|---|---|
|
PAP Adherence
|
2.16 hours per night
Standard Error 0.26
|
0.87 hours per night
Standard Error 0.19
|
SECONDARY outcome
Timeframe: 6 months following randomizationTotal score on the Pittsburgh Sleep Quality Index will be used as a measure of sleep quality. Scores range from 0 to 21. Higher scores indicate worse outcome.
Outcome measures
| Measure |
PAP Adherence Program
n=53 Participants
Manual-based program provided by supervised allied health personnel focused on PAP adherence with behavioral strategies to improve PAP adherence and sleep.
|
Active Control
n=53 Participants
Manual-based general sleep education program provided by supervised allied health personnel.
|
|---|---|---|
|
Sleep Quality
|
7.72 score on a scale
Standard Error 0.60
|
8.01 score on a scale
Standard Error 0.59
|
SECONDARY outcome
Timeframe: 6 months following randomizationTotal score on the Epworth Sleepiness Scale will be used as a measure of daytime sleepiness. Score range from 0-24. Higher scores indicate worse outcome.
Outcome measures
| Measure |
PAP Adherence Program
n=53 Participants
Manual-based program provided by supervised allied health personnel focused on PAP adherence with behavioral strategies to improve PAP adherence and sleep.
|
Active Control
n=53 Participants
Manual-based general sleep education program provided by supervised allied health personnel.
|
|---|---|---|
|
Daytime Sleepiness
|
6.11 score on a scale
Standard Error 0.67
|
7.59 score on a scale
Standard Error 0.67
|
SECONDARY outcome
Timeframe: 6 months following randomizationTotal score on the Functional Outcomes of Sleep Questionnaire (FOSQ-10) will be used as a measure of sleep-related function. Scores range from 5-20. Lower scores indicate worse outcome.
Outcome measures
| Measure |
PAP Adherence Program
n=53 Participants
Manual-based program provided by supervised allied health personnel focused on PAP adherence with behavioral strategies to improve PAP adherence and sleep.
|
Active Control
n=53 Participants
Manual-based general sleep education program provided by supervised allied health personnel.
|
|---|---|---|
|
Sleep-related Function
|
14.65 score on a scale
Standard Error 0.50
|
15.67 score on a scale
Standard Error 0.50
|
Adverse Events
PAP Adherence Program
Serious events: 6 serious events
Other events: 0 other events
Deaths: 1 deaths
Active Control
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
PAP Adherence Program
n=53 participants at risk
Manual-based program provided by supervised allied health personnel focused on PAP adherence with behavioral strategies to improve PAP adherence and sleep.
|
Active Control
n=53 participants at risk
Manual-based general sleep education program provided by supervised allied health personnel.
|
|---|---|---|
|
Psychiatric disorders
Mental health distress
|
1.9%
1/53 • Number of events 1 • One year following randomization.
|
0.00%
0/53 • One year following randomization.
|
|
Infections and infestations
Hospitalization
|
5.7%
3/53 • Number of events 6 • One year following randomization.
|
0.00%
0/53 • One year following randomization.
|
|
Cardiac disorders
Hospitalization
|
3.8%
2/53 • Number of events 2 • One year following randomization.
|
1.9%
1/53 • Number of events 1 • One year following randomization.
|
|
General disorders
Hospitalization
|
1.9%
1/53 • Number of events 1 • One year following randomization.
|
0.00%
0/53 • One year following randomization.
|
|
Renal and urinary disorders
Hospitalization
|
1.9%
1/53 • Number of events 1 • One year following randomization.
|
0.00%
0/53 • One year following randomization.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Cathy Alessi
VA Greater Los Angeles Healthcare System
Phone: 818 891-7711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place