NCT04759157

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

June 16, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

December 10, 2024

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

1.5 years

First QC Date

February 13, 2021

Results QC Date

March 21, 2024

Last Update Submit

December 6, 2024

Conditions

Obstructive Sleep Apnea

Keywords

OSA

Outcome Measures

Primary Outcomes (1)

  • 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)

    study duration

Secondary Outcomes (2)

  • Percentage of Days With PAP Use of 4 Hours or More

    3 months

  • Self-reported Sleep Disturbance

    3 months

Other Outcomes (2)

  • Intervention Completion

    intervention period, 1 month

  • Retention

    3 months

Study Arms (4)

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.

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.

Behavioral: Couples-based treatment

Information Control- Patient

ACTIVE COMPARATOR

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

Other: Standardized education

Information Control- Partner

ACTIVE COMPARATOR

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

Other: Standardized education

Interventions

Couples-based treatmentBEHAVIORAL

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

Couples-based treatment- PartnerCouples-based treatment- Patient
Standardized educationOTHER

Patients will receive standardized educational materials

Information Control- PartnerInformation Control- Patient

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \. 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)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

  • 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.

    PMID: 35933417DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Limitations and Caveats

Limitations include: small sample size, enrollment at a single academic sleep center, primarily White sample with high educational attainment.

Results Point of Contact

Title
Dr. Kelly Baron
Organization
University of Utah
kelly.baron@utah.edu
801-585-7588

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This is a dyadic study. Couples are randomly assigned as a dyad.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 13, 2021

First Posted

February 18, 2021

Study Start

June 16, 2021

Primary Completion

December 16, 2022

Study Completion

January 31, 2023

Last Updated

December 10, 2024

Results First Posted

December 10, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Data will be made available upon request

Shared Documents
STUDY PROTOCOL, SAP, 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

Locations

US(1)