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We-PAP: A Couples-based Intervention for Sleep Apnea

NCT ID: NCT04759157

Last Updated: 2024-12-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-16

Study Completion Date

2023-01-31

Brief Summary

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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).

Detailed Description

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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

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Obstructive Sleep Apnea

Keywords

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OSA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a dyadic study. Couples are randomly assigned as a dyad.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Couples-based treatment

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Couples-based treatment

Intervention Type BEHAVIORAL

Couples will attend 3, video based sessions for couples-based treatment

Information Control- Patient

Participants will receive treatment as usual and also standardized information about OSA and CPAP.

Group Type ACTIVE_COMPARATOR

Standardized education

Intervention Type OTHER

Patients will receive standardized educational materials

Information Control- Partner

Participants will receive treatment as usual and also standardized information about OSA and CPAP.

Group Type ACTIVE_COMPARATOR

Standardized education

Intervention Type OTHER

Patients will receive standardized educational materials

Interventions

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Couples-based treatment

Couples will attend 3, video based sessions for couples-based treatment

Intervention Type BEHAVIORAL

Standardized education

Patients will receive standardized educational materials

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age \>=50
2. Access to cellular (active data plan) or Wi-Fi, in order to complete the telehealth intervention.


1. Diagnosed with OSA (AHI\>10 or AHI\>5 with impairment) and intend to start PAP treatment
2. PAP naïve or non-use of PAP for at least 3 years
3. Married or cohabiting with a romantic partner for \>1 year
4. Able to read/write English.


1. Able to read/write English
2. PROMIS sleep disturbance score \>55 in either patient or partner, or desire to improve sleep.

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).


1. High risk or presence of moderate to severe comorbid sleep disorders (i.e., restless legs syndrome)
2. History of cognitive or neurological disorders (e.g., dementia, Parkinson's, Multiple Sclerosis)
3. 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)
4. Unstable or serious medical illness that would interfere with participation (cancer, renal disease on dialysis, moderate to severe COPD)
5. Use of ASV, VPAP or supplemental oxygen
6. Overnight work \> 1x per month
7. Pregnancy/ desire to become pregnant in the study period
8. Current participation in behavioral sleep treatment (e.g., CBT-I) or completion of CBT-I in the past 3 years
9. Concurrent participation in another clinical trial
10. Caregiving for an infant \< 2 years old or adult who requires overnight assistance.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

RAND

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Kelly Glazer Baron

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35933417 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R21AG067183-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00135927

Identifier Type: -

Identifier Source: org_study_id