Recruiting

CPAP Adherence

Sponsor:

MetroHealth Medical Center

Code:

NCT05955287

Conditions

Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Telemonitoring

Peer Based

CPAP Education

Usual Care

Study Details

Brief summary:

The goal of the study is to determine the feasibility of a behavioral intervention to improve CPAP adherence among African American patients with obstructive sleep apnea.

Conditions

Sleep Apnea

Study ID

NCT05955287

Start date

Feb 1, 2023

Status verified date

Jul, 2023

Completion date

May 1, 2024

Anticipated

Primary completion date

May 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Must have same bed partner(s) for at least 6 months.
  • Must be at least 18 years of age

Exclusion Criteria:

  • Must be Proficient in speaking English
  • Non-compliance to management of OSA
  • Apnea hypopnea Index ≥ 15 events/hours
  • Terminally ill
  • Mentally incompetent
  • unstable housing
  • need for BPAP or VPAP\\PAP).

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Couple Intervention

Patients will receive usual care. In addition, they will participate in virtual OSA support groups led by an African American peer-motivator patient with long-standing OSA and their bed partner. Peer-motivator couples will be trained and certified as competent prior to interacting with study participants. They will share their experiences with managing OSA including coping strategies to maximize CPAP adherence.

Telemonitoring. Patients and bed partners will receive text messages encouraging CPAP adherence.

active comparator: Control

Patients with CPAP technical difficulties will be encouraged to contact the sleep technologist for assistance. Patients will also attend a 90-minute virtual webinar and question-answer session on hypertension management (1 month), cancer screening (3 months), and weight management (6 months) led by African American physicians with expertise in each topic.

Interventions

Telemonitoring

Text messages of encouragement will be sent to patients and partners. No more than 2 messages will be sent per week to prevent respondent fatigue.

Peer Based

Patients and partners will attend OSA virtual support groups led by an African American patient with long-standing OSA and their bed partner. Peer-motivator couples will be trained and certified as competent prior to interacting with study participants. They will share their experiences with managing OSA including coping strategies to maximize CPAP adherence.

CPAP Education

Patients with OSA and their bed partners will participate in two 1-hour video support groups at 2 weeks and 2 months ran by patients with OSA and their bed partners

Usual Care

Participants will receive OSA education and CPAP training from providers trained in OSA management.

Primary outcome measure

  • CPAP Adherence [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Locations

MetroHealth Medical System

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

More Information

Sponsor

MetroHealth Medical Center

Last update posted

Jul 21, 2023

Last verified

Jul, 2023

Keywords

  • obstructive sleep apnea

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MetroHealth Medical Center on 2023-07-21.