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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04759157
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : November 10, 2021
Sponsor:
Collaborators:
National Institute on Aging (NIA)
RAND
Information provided by (Responsible Party):
Kelly Glazer Baron, University of Utah

Study Description
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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).

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Behavioral: Couples-based treatment Other: Standardized education Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes 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.
Primary Purpose: Other
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
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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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.
 Behavioral: Couples-based treatment
Couples will attend 3, video based sessions for couples-based treatment
Standard Information Control
Participants will receive treatment as usual and also standardized information about OSA and CPAP.
 Other: Standardized education
Patients will receive standardized educational materials


Outcome Measures
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Primary Outcome Measures :
  1. Hours of CPAP use [ Time Frame: 3 months ]
    Patient adherence to CPAP will be measured via download of their machine


Secondary Outcome Measures :
  1. 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

  2. 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


Other Outcome Measures:
  1. Relationship satisfaction [ Time Frame: 1 and 3 months ]
    Patient and partner relationship quality will be measured via self-report

  2. Cognitive functioning [ Time Frame: 3 months ]
    Patient and partner change in cognitive functioning will be measured using the RBANS instrument


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patient and partner inclusion criteria:

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

Patients inclusion criteria:

  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.

Partner inclusion criteria:

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

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:

  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04759157


Contacts
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Contact: Kelly Baron, Ph.D. 8015857588 kelly.baron@utah.edu
Contact: Giulia De Vettori 8015857588 giulia.devettori@utah.edu

Locations
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United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Giulia DeVettori    801-585-7588    giulia.devettori@utah.edu   
Sponsors and Collaborators
University of Utah
National Institute on Aging (NIA)
RAND
More Information
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Responsible Party: Kelly Glazer Baron, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT04759157    
Other Study ID Numbers: 00135927
1R21AG067183-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made available upon request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Within 1 year of completion of the study, will be available for 3 years.
Access Criteria: Written request to the PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kelly Glazer Baron, University of Utah:
OSA
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases