Back to resultsWe-PAP: A Couples-based Intervention for Sleep Apnea (We-PAP)
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Couples-based treatment
Standardized education
Sponsored by
About this trial
This is an interventional other trial for Obstructive Sleep Apnea focused on measuring OSA
Eligibility Criteria
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.
Sites / Locations
- University of Utah
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Couples-based treatment
Standard Information Control
Arm Description
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.
Participants will receive treatment as usual and also standardized information about OSA and CPAP.
Outcomes
Primary Outcome Measures
Hours of CPAP use
Patient adherence to CPAP will be measured via download of their machine
Secondary Outcome Measures
Self-reported sleep
Patient and partner self-reported sleep quality will be measured using the PROMIS sleep disturbance measure at baseline, 1 and 3 months
Objective sleep
Patient and partner objective sleep quality will be measured using actigraphy at baseline, 1 and 3 months
Full Information
NCT ID
NCT04759157
First Posted
February 13, 2021
Last Updated
February 8, 2023
Sponsor
University of Utah
Collaborators
National Institute on Aging (NIA), RAND
1. Study Identification
Unique Protocol Identification Number
NCT04759157
Brief Title
We-PAP: A Couples-based Intervention for Sleep Apnea
Acronym
We-PAP
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
December 16, 2022 (Actual)
Study Completion Date
January 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
National Institute on Aging (NIA), RAND
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
OSA
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Couples-based treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Information Control
Arm Type
Other
Arm Description
Participants will receive treatment as usual and also standardized information about OSA and CPAP.
Intervention Type
Behavioral
Intervention Name(s)
Couples-based treatment
Intervention Description
Couples will attend 3, video based sessions for couples-based treatment
Intervention Type
Other
Intervention Name(s)
Standardized education
Intervention Description
Patients will receive standardized educational materials
Primary Outcome Measure Information:
Title
Hours of CPAP use
Description
Patient adherence to CPAP will be measured via download of their machine
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Self-reported sleep
Description
Patient and partner self-reported sleep quality will be measured using the PROMIS sleep disturbance measure at baseline, 1 and 3 months
Time Frame
1 and 3 months
Title
Objective sleep
Description
Patient and partner objective sleep quality will be measured using actigraphy at baseline, 1 and 3 months
Time Frame
1 month and 3 months
Other Pre-specified Outcome Measures:
Title
Relationship satisfaction
Description
Patient and partner relationship quality will be measured via self-report
Time Frame
1 and 3 months
Title
Cognitive functioning
Description
Patient and partner change in cognitive functioning will be measured using the RBANS instrument
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made available upon request
IPD Sharing Time Frame
Within 1 year of completion of the study, will be available for 3 years.
IPD Sharing Access Criteria
Written request to the PI
Citations:
PubMed Identifier
35933417
Citation
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.
Results Reference
derived
Learn more about this trial
We-PAP: A Couples-based Intervention for Sleep Apnea
We'll reach out to this number within 24 hrs