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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AG067183-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| RAND | OTHER |
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The purpose of this study is to develop, refine and evaluate the feasibility of a novel couples-based intervention to improve adherence for patients with obstructive sleep apnea (OSA).
This study will develop and test a novel couples-based intervention for the treatment of OSA and sleep health among older couples. The focus of this study is patient who are starting CPAP treatment and their partners. Couples will be randomized to a 3-session sleep health intervention delivered via telehealth or to standard educational support for CPAP. The intervention is based on a transdiagnostic model of sleep and circadian disorders (TransS-C) and rooted in the idea that older adults with OSA are often also having other sleep problems, and that OSA is best treated in the couples context.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Couples-based treatment- Patient | Experimental | 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- Partner | Experimental | 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. |
|
| Information Control- Patient | Active Comparator | Participants will receive treatment as usual and also standardized information about OSA and CPAP. |
|
| Information Control- Partner | Active Comparator | Participants will receive treatment as usual and also standardized information about OSA and CPAP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Couples-based treatment | Behavioral | Couples will attend 3, video based sessions for couples-based treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Feasibility | 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) | study duration |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Days With PAP Use of 4 Hours or More | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Completion | 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 | intervention period, 1 month |
| Retention |
Inclusion Criteria:
Patient and partner inclusion criteria:
Patients inclusion criteria:
Partner inclusion criteria:
Exclusion Criteria:
Patient only exclusion criteria:
1. Concomitant OSA treatments (bariatric surgery planned in the next 3 months or bariatric surgery in the past year, ear nose and throat surgery for sleep apnea occurring in the 3 months before or planning for within the study period).
Exclusion criteria for both patient and partner include the following:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35933417 | Derived | Baron KG, Gilles A, Sundar KM, Baucom BRW, Duff K, Troxel W. Rationale and study protocol for We-PAP: a randomized pilot/feasibility trial of a couples-based intervention to promote PAP adherence and sleep health compared to an educational control. Pilot Feasibility Stud. 2022 Aug 6;8(1):171. doi: 10.1186/s40814-022-01089-x. |
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Data will be made available upon request
Within 1 year of completion of the study, will be available for 3 years.
Written request to the PI
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Participants were recruited if they were planning to begin PAP treatment for obstructive sleep apnea.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | Information Control- Patient | Treatment as usual plus standardized educational materials |
| FG003 | Information Control- Partner | Treatment as usual plus standardized educational materials |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
84 individuals (42 couples) initially consented and 74 individuals (37) completed baseline assessments. A total of 10 participants (5 couples) were removed or declined to continue to baseline (4 couples became inelgibile and 1 declined)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment Feasibility | 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) | Posted | Count of Participants | Participants | study duration |
|
3 months
Adverse reports were collected if reported by the participants in intervention sessions or assessment visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Couples-based Treatment- Patient | Couples-based treatment: Couples will attend 3, video based sessions for couples-based treatment |
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Limitations include: small sample size, enrollment at a single academic sleep center, primarily White sample with high educational attainment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kelly Baron | University of Utah | 801-585-7588 | kelly.baron@utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 9, 2020 | Feb 2, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 12, 2020 | Feb 2, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 29, 2021 | Feb 2, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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This is a dyadic study. Couples are randomly assigned as a dyad.
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Investigators and outcomes assessors will not have knowledge of the randomization table. Participants will be reminded to not to tell the outcomes assessors their group. Only the statistician and interventionist will be aware of the group.
| Standardized education | Other | Patients will receive standardized educational materials |
|
| 3 months |
| Self-reported Sleep Disturbance | 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. | 3 months |
We defined retention as the number of participants completing the 3 month follow-up. Our goal was to acheive at least 85% retention.
| 3 months |
| BG001 |
| 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 |
| BG002 | Standard Information Control- Patient | Participants will receive treatment as usual and also standardized information about OSA and CPAP. Standardized education: Patients will receive standardized educational materials |
| BG003 | Standard Information Control- Partner | Participants will receive treatment as usual and also standardized information about OSA and CPAP. Standardized education: Patients will receive standardized educational materials |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | 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) | Mean | Standard Deviation | years |
|
| Sex: Female, Male | 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) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Percentage of Days With PAP Use of 4 Hours or More | 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). | Patients who had their PAP machine removed were given a zero at 3 months (n=2 patients) | Posted | Mean | Standard Deviation | proportion of nights with CPAP >=4h | 3 months |
|
|
|
|
| Secondary | Self-reported Sleep Disturbance | 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. | Baseline PROMIS sleep quality data are missing for this variable for one couple in the intervention group and one couple in the control group | Posted | Mean | Standard Deviation | t-score | 3 months |
|
|
|
|
| Other Pre-specified | Intervention Completion | 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 | 100% of participants completed the planned intervention for their assigned group. | Posted | Count of Participants | Participants | intervention period, 1 month |
|
|
|
| Other Pre-specified | Retention | We defined retention as the number of participants completing the 3 month follow-up. Our goal was to acheive at least 85% retention. | We acheived 100% retention, with all participants completing the 3 month follow-up assessment. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Couples-based Treatment- Partner | Couples-based treatment: Couples will attend 3, video based sessions for couples-based treatment | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Standard Information Control- Patient | Standardized education: Patients will receive standardized educational materials plus one phone call | 0 | 17 | 0 | 17 | 0 | 17 |
| EG003 | Standard Information Control- Partner | Standardized education: Patients will receive standardized educational materials plus one phone call | 0 | 17 | 0 | 17 | 0 | 17 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
|
| 3 months |
|
|