Trial Outcomes & Findings for We-PAP: A Couples-based Intervention for Sleep Apnea (NCT NCT04759157)
NCT ID: NCT04759157
Last Updated: 2024-12-10
Results Overview
Defined as the ability to achieve the recruitment goals of the study, to recruit approximately 3-4 couples per month over the study period (12 months)
COMPLETED
NA
84 participants
study duration
2024-12-10
Participant Flow
Participants were recruited from June 2021 to October 2023 from the University of Utah Sleep Wake Center among patients who were undergoing sleep apnea testing (polysomnography and home sleep testing) for suspected sleep apnea. 84 participants were consented and 74 continued to baseline assessment. A total of 10 individuals (5 couples) did not complete baseline for the following reason: 4 couples became ineligible (did not start PAP, started oxygen), 1 couple did not complete baseline.
Participants were recruited if they were planning to begin PAP treatment for obstructive sleep apnea.
Participant milestones
| Measure |
Couples-based Treatment- Patient
Participants will attend 3, sessions (75, 50, 50 min) over video with a study therapist to discuss education about OSA and CPAP, strategies adjust to CPAP as a couple and techniques to improve sleep health.
Couples-based treatment: Couples will attend 3, video based sessions for couples-based treatment
|
Couples Based Treatment- Partner
Participants will attend 3, sessions (75, 50, 50 min) over video with a study therapist to discuss education about OSA and CPAP, strategies adjust to CPAP as a couple and techniques to improve sleep health.
Couples-based treatment: Couples will attend 3, video based sessions for couples-based treatment
|
Information Control- Patient
Treatment as usual plus standardized educational materials
|
Information Control- Partner
Treatment as usual plus standardized educational materials
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
17
|
17
|
|
Overall Study
COMPLETED
|
20
|
20
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data from 5 couples were removed from the analyses for the following reasons: Machine taken away before 3 months (n=2), random responding (n=1), cognitive impairment (n=1)
Baseline characteristics by cohort
| Measure |
Couples-based Treatment- Patient
n=20 Participants
Participants will attend 3, sessions (75, 50, 50 min) over video with a study therapist to discuss education about OSA and CPAP, strategies adjust to CPAP as a couple and techniques to improve sleep health.
Couples-based treatment: Couples will attend 3, video based sessions for couples-based treatment
|
Couples-based Treatment- Partner
n=20 Participants
Participants will attend 3, sessions (75, 50, 50 min) over video with a study therapist to discuss education about OSA and CPAP, strategies adjust to CPAP as a couple and techniques to improve sleep health.
Couples-based treatment: Couples will attend 3, video based sessions for couples-based treatment
|
Standard Information Control- Patient
n=17 Participants
Participants will receive treatment as usual and also standardized information about OSA and CPAP.
Standardized education: Patients will receive standardized educational materials
|
Standard Information Control- Partner
n=17 Participants
Participants will receive treatment as usual and also standardized information about OSA and CPAP.
Standardized education: Patients will receive standardized educational materials
|
Total
n=74 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 7.4 • n=5 Participants • Data from 5 couples were removed from the analyses for the following reasons: Machine taken away before 3 months (n=2), random responding (n=1), cognitive impairment (n=1)
|
59.9 years
STANDARD_DEVIATION 7.7 • n=7 Participants • Data from 5 couples were removed from the analyses for the following reasons: Machine taken away before 3 months (n=2), random responding (n=1), cognitive impairment (n=1)
|
66.1 years
STANDARD_DEVIATION 8.8 • n=5 Participants • Data from 5 couples were removed from the analyses for the following reasons: Machine taken away before 3 months (n=2), random responding (n=1), cognitive impairment (n=1)
|
64.3 years
STANDARD_DEVIATION 11.6 • n=4 Participants • Data from 5 couples were removed from the analyses for the following reasons: Machine taken away before 3 months (n=2), random responding (n=1), cognitive impairment (n=1)
|
63.2 years
STANDARD_DEVIATION 8.8 • n=21 Participants • Data from 5 couples were removed from the analyses for the following reasons: Machine taken away before 3 months (n=2), random responding (n=1), cognitive impairment (n=1)
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants • Data from 5 couples were removed from the analyses for the following reasons: Machine taken away before 3 months (n=2), random responding (n=1), cognitive impairment (n=1)
|
11 Participants
n=7 Participants • Data from 5 couples were removed from the analyses for the following reasons: Machine taken away before 3 months (n=2), random responding (n=1), cognitive impairment (n=1)
|
8 Participants
n=5 Participants • Data from 5 couples were removed from the analyses for the following reasons: Machine taken away before 3 months (n=2), random responding (n=1), cognitive impairment (n=1)
|
9 Participants
n=4 Participants • Data from 5 couples were removed from the analyses for the following reasons: Machine taken away before 3 months (n=2), random responding (n=1), cognitive impairment (n=1)
|
37 Participants
n=21 Participants • Data from 5 couples were removed from the analyses for the following reasons: Machine taken away before 3 months (n=2), random responding (n=1), cognitive impairment (n=1)
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants • Data from 5 couples were removed from the analyses for the following reasons: Machine taken away before 3 months (n=2), random responding (n=1), cognitive impairment (n=1)
|
9 Participants
n=7 Participants • Data from 5 couples were removed from the analyses for the following reasons: Machine taken away before 3 months (n=2), random responding (n=1), cognitive impairment (n=1)
|
9 Participants
n=5 Participants • Data from 5 couples were removed from the analyses for the following reasons: Machine taken away before 3 months (n=2), random responding (n=1), cognitive impairment (n=1)
|
8 Participants
n=4 Participants • Data from 5 couples were removed from the analyses for the following reasons: Machine taken away before 3 months (n=2), random responding (n=1), cognitive impairment (n=1)
|
37 Participants
n=21 Participants • Data from 5 couples were removed from the analyses for the following reasons: Machine taken away before 3 months (n=2), random responding (n=1), cognitive impairment (n=1)
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
17 participants
n=5 Participants
|
17 participants
n=4 Participants
|
74 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: study durationDefined as the ability to achieve the recruitment goals of the study, to recruit approximately 3-4 couples per month over the study period (12 months)
Outcome measures
| Measure |
Patients
n=42 Participants
Patients recently diagnosed with obstructive sleep apnea (pre-randomization)
|
Partners
n=42 Participants
Partners of patients recently diagnosed with obstructive sleep apnea (OSA), pre-randomization
|
Standard Information Control- Patient
Information plus one follow-up phone call
|
Standard Information Control- Partner
Information plus one follow-up phone call
|
|---|---|---|---|---|
|
Recruitment Feasibility
|
42 Participants
|
42 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Patients who had their PAP machine removed were given a zero at 3 months (n=2 patients)
The primary efficacy measure for this pilot trial was the percentage of days that patients used CPAP for 4 hours or more over the first 3 months. This 4 hour cutoff was selected becasue it is the minimum usage defined by Medicare and other insurance companies. We obtained patients' CPAP usage by downloading data from their machine using a remote dashboard. Data are only available for patients because partners were not using the treatment. This variable is defined as a proportion, calculated as the number of days with CPAP usage of 4 hours or more divided by the total number of days collected in the 3 month recording period. Scores can range from 0 (no days with use to 1, indicating all days with use of 4 hours or more).
Outcome measures
| Measure |
Patients
n=20 Participants
Patients recently diagnosed with obstructive sleep apnea (pre-randomization)
|
Partners
n=17 Participants
Partners of patients recently diagnosed with obstructive sleep apnea (OSA), pre-randomization
|
Standard Information Control- Patient
Information plus one follow-up phone call
|
Standard Information Control- Partner
Information plus one follow-up phone call
|
|---|---|---|---|---|
|
Percentage of Days With PAP Use of 4 Hours or More
|
.73 proportion of nights with CPAP >=4h
Standard Deviation .08
|
.72 proportion of nights with CPAP >=4h
Standard Deviation .07
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Baseline PROMIS sleep quality data are missing for this variable for one couple in the intervention group and one couple in the control group
Patient sleep quality on the Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance scale, 8 item, version 8b. Models evaluated change from baseline to 3 months. Raw are converted to t-scores, with a range of 28.9-76.5, a mean of 50 and a SD of 10. Higher scores indicate poorer sleep subjective quality.
Outcome measures
| Measure |
Patients
n=20 Participants
Patients recently diagnosed with obstructive sleep apnea (pre-randomization)
|
Partners
n=20 Participants
Partners of patients recently diagnosed with obstructive sleep apnea (OSA), pre-randomization
|
Standard Information Control- Patient
n=17 Participants
Information plus one follow-up phone call
|
Standard Information Control- Partner
n=17 Participants
Information plus one follow-up phone call
|
|---|---|---|---|---|
|
Self-reported Sleep Disturbance
Baseline
|
55.3 t-score
Standard Deviation 6.8
|
50.6 t-score
Standard Deviation 5.7
|
56.7 t-score
Standard Deviation 7.8
|
48.6 t-score
Standard Deviation 6.4
|
|
Self-reported Sleep Disturbance
3 months
|
49.6 t-score
Standard Deviation 5.9
|
48.3 t-score
Standard Deviation 6.3
|
51 t-score
Standard Deviation 6.1
|
48.7 t-score
Standard Deviation 6.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: intervention period, 1 monthPopulation: 100% of participants completed the planned intervention for their assigned group.
Percentage of participants who completed the intervention sessions: 3 sessions for the couples-based treatment group and 1 handout and phone call for the information control group
Outcome measures
| Measure |
Patients
n=20 Participants
Patients recently diagnosed with obstructive sleep apnea (pre-randomization)
|
Partners
n=20 Participants
Partners of patients recently diagnosed with obstructive sleep apnea (OSA), pre-randomization
|
Standard Information Control- Patient
n=17 Participants
Information plus one follow-up phone call
|
Standard Information Control- Partner
n=17 Participants
Information plus one follow-up phone call
|
|---|---|---|---|---|
|
Intervention Completion
|
20 Participants
|
20 Participants
|
17 Participants
|
17 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: We acheived 100% retention, with all participants completing the 3 month follow-up assessment.
We defined retention as the number of participants completing the 3 month follow-up. Our goal was to acheive at least 85% retention.
Outcome measures
| Measure |
Patients
n=20 Participants
Patients recently diagnosed with obstructive sleep apnea (pre-randomization)
|
Partners
n=20 Participants
Partners of patients recently diagnosed with obstructive sleep apnea (OSA), pre-randomization
|
Standard Information Control- Patient
n=17 Participants
Information plus one follow-up phone call
|
Standard Information Control- Partner
n=17 Participants
Information plus one follow-up phone call
|
|---|---|---|---|---|
|
Retention
|
20 Participants
|
20 Participants
|
17 Participants
|
17 Participants
|
Adverse Events
Couples-based Treatment- Patient
Couples-based Treatment- Partner
Standard Information Control- Patient
Standard Information Control- Partner
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