Obstructive Sleep ApneaWe-PAPNCT04759157
We-PAP: A Couples-based Intervention for Sleep Apnea
A study testing Couples-based treatment and Standardized education in people with Obstructive Sleep Apnea, run by University of Utah at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Couples-based treatment and Standardized education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2021to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient and partner inclusion criteria:
- Age >=50
- Access to cellular (active data plan) or Wi-Fi, in order to complete the telehealth intervention.
- Patients inclusion criteria:
- Diagnosed with OSA (AHI>10 or AHI>5 with impairment) and intend to start PAP treatment
- PAP naïve or non-use of PAP for at least 3 years
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- Married or cohabiting with a romantic partner for >1 year
- Able to read/write English.
- Partner inclusion criteria:
- Able to read/write English
- PROMIS sleep disturbance score >55 in either patient or partner, or desire to improve sleep.
Who cannot join
- 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:
- High risk or presence of moderate to severe comorbid sleep disorders (i.e., restless legs syndrome)
- History of cognitive or neurological disorders (e.g., dementia, Parkinson's, Multiple Sclerosis)
- Presence of major psychiatric disorders (e.g., schizophrenia, bipolar disorder), alcohol abuse reported on the Audit-C (score >4 for men, >3 for women), drug use (NIDA-Modified ASSIST score >3)
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- Unstable or serious medical illness that would interfere with participation (cancer, renal disease on dialysis, moderate to severe COPD)
- Use of ASV, VPAP or supplemental oxygen
- Overnight work > 1x per month
- Pregnancy/ desire to become pregnant in the study period
- Current participation in behavioral sleep treatment (e.g., CBT-I) or completion of CBT-I in the past 3 years
- Concurrent participation in another clinical trial
- Caregiving for an infant < 2 years old or adult who requires overnight assistance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Couples- Based Sleep Health Intervention For Older Adults With Obstructive Sleep Apnea: Implications for Alzheimer's Disease Risk And Healthy Aging
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).
Read the detailed description
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Couples-based treatment, Standardized education
- Keywords
- OSA
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couples-based treatmentBehavioural
Couples will attend 3, video based sessions for couples-based treatment
Standardized educationOther
Patients will receive standardized educational materials
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Couples-based treatment |
| 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. Receives: Behavioral: Couples-based treatment |
| Information Control- Patient | Active comparator | Participants will receive treatment as usual and also standardized information about OSA and CPAP. Receives: Other: Standardized education |
| Information Control- Partner | Active comparator | Participants will receive treatment as usual and also standardized information about OSA and CPAP. Receives: Other: Standardized education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: study duration
Secondary outcomes (2)
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).
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start16 Jun 2021
- Primary completion16 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a dyadic study. Couples are randomly assigned as a dyad.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), RAND
- Responsible party
- Principal investigator, Kelly Glazer Baron, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759157
- Sponsor's protocol ID
- 00135927
- Other IDs
- 1R21AG067183-01A1
- Acronym
- We-PAP
- Status last verified
- Dec 2024
- First submitted
- 13 Feb 2021
- Last updated
- 10 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon request
Publications
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.
PubMed 35933417
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Couples- Based Sleep Health Intervention For Older Adults With Obstructive Sleep Apnea: Implications for Alzheimer's Disease Risk And Healthy Aging
- ClinicalTrials.gov ID
- NCT04759157
- Acronym / sponsor ID
- We-PAP / 00135927
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), RAND
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Posted 10 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a dyadic study. Couples are randomly assigned as a dyad.
| Arm | Type | Receives |
|---|---|---|
| Couples-based treatment- Patient | Experimental | Behavioral: Couples-based treatmentParticipants 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 | Behavioral: Couples-based treatmentParticipants 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 | Other: Standardized educationParticipants will receive treatment as usual and also standardized information about OSA and CPAP. |
| Information Control- Partner | Active comparator | Other: Standardized educationParticipants will receive treatment as usual and also standardized information about OSA and CPAP. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age >=50
- Access to cellular (active data plan) or Wi-Fi, in order to complete the telehealth intervention.
- Diagnosed with OSA (AHI>10 or AHI>5 with impairment) and intend to start PAP treatment
- PAP naïve or non-use of PAP for at least 3 years
- Married or cohabiting with a romantic partner for >1 year
Key exclusion criteria (13 listed)
- 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).
- High risk or presence of moderate to severe comorbid sleep disorders (i.e., restless legs syndrome)
- History of cognitive or neurological disorders (e.g., dementia, Parkinson's, Multiple Sclerosis)
- Presence of major psychiatric disorders (e.g., schizophrenia, bipolar disorder), alcohol abuse reported on the Audit-C (score >4 for men, >3 for women), drug use (NIDA-Modified ASSIST score >3)
- Unstable or serious medical illness that would interfere with participation (cancer, renal disease on dialysis, moderate to severe COPD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Couples-based treatmentCouples will attend 3, video based sessions for couples-based treatment | Behavioural | Couples-based treatment- Partner, Couples-based treatment- Patient |
| Standardized educationPatients will receive standardized educational materials | Other | Information Control- Partner, Information Control- Patient |
Primary outcome
Recruitment Feasibility
Time frame: study duration
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)
2 secondary outcomes
Percentage of Days With PAP Use of 4 Hours or More
Time frame: 3 months
Self-reported Sleep Disturbance
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35933417Baron 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.
- Individual participant dataSharing planned: Yes. Data will be made available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couples-based treatment and Standardized education in people with Obstructive Sleep Apnea, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (time frame: study duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04759157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.