- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04759157
We-PAP: A Couples-based Intervention for Sleep Apnea (We-PAP)
A Novel Couples- Based Sleep Health Intervention For Older Adults With Obstructive Sleep Apnea: Implications for Alzheimer's Disease Risk And Healthy Aging
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84108
- University of Utah
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
- 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.
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:
- 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)
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Couples-based treatment
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 will attend 3, video based sessions for couples-based treatment
|
OTHER: Standard Information Control
Participants will receive treatment as usual and also standardized information about OSA and CPAP.
|
Patients will receive standardized educational materials
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hours of CPAP use
Time Frame: 3 months
|
Patient adherence to CPAP will be measured via download of their machine
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported sleep
Time Frame: 1 and 3 months
|
Patient and partner self-reported sleep quality will be measured using the PROMIS sleep disturbance measure at baseline, 1 and 3 months
|
1 and 3 months
|
Objective sleep
Time Frame: 1 month and 3 months
|
Patient and partner objective sleep quality will be measured using actigraphy at baseline, 1 and 3 months
|
1 month and 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relationship satisfaction
Time Frame: 1 and 3 months
|
Patient and partner relationship quality will be measured via self-report
|
1 and 3 months
|
Cognitive functioning
Time Frame: 3 months
|
Patient and partner change in cognitive functioning will be measured using the RBANS instrument
|
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00135927
- 1R21AG067183-01A1 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obstructive Sleep Apnea
-
LivaNovaRecruitingApnea | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | Apnea+Hypopnea | Apnea, Obstructive Sleep | Hypopnea, SleepUnited States
-
Mauro ManconiCompletedObstructive Sleep Apnea Syndrome | Sleep Apnea, Obstructive | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | OSAHSwitzerland
-
University of California, Los AngelesRecruiting
-
Brigham and Women's HospitalCompletedObstructive Sleep Apnea (OSA)United States
-
State Budgetary Healthcare Institution, National...RecruitingObstructive Sleep Apnea | Obstructive Sleep Apnea-hypopnea | Obstructive Sleep Apnea-hypopnea SyndromeRussian Federation
-
The Hospital for Sick ChildrenCompleted
-
Cryosa, Inc.Active, not recruitingObstructive Sleep Apnea of AdultPanama, Paraguay
-
State Key Laboratory of Respiratory DiseaseCompletedObstructive Sleep Apnea of AdultChina
-
Somnics, Inc.UnknownObstructive Sleep Apnea of AdultTaiwan
-
ApnimedCompletedOSA - Obstructive Sleep ApneaUnited States
Clinical Trials on Couples-based treatment
-
Vancouver Prostate CentreCompletedSexual Dysfunction | Prostate CancerCanada
-
Duke UniversityNational Cancer Institute (NCI)CompletedBreast CancerUnited States
-
University of UtahCompletedDepression | Stroke | Depressive Symptoms | Post-stroke DepressionUnited States
-
Vanderbilt University Medical CenterNational Institute of Mental Health (NIMH)CompletedHuman Immunodeficiency VirusMozambique
-
Yale UniversityWithdrawnAlcohol Dependence | PTSDUnited States
-
Columbia UniversityCompleted
-
Virginia Commonwealth UniversityDepartment of Health and Human ServicesCompletedTraumatic Brain Injury | Acquired Brain InjuryUnited States
-
University of Notre DameEunice Kennedy Shriver National Institute of Child Health and Human Development...Active, not recruitingBehavior, InfantUnited States
-
Baylor College of MedicineNational Cancer Institute (NCI)Completed