Motivational Enhancement Therapy for Heart Failure and Sleep Apnea

Overseen By Cinthya Pena Orbea, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Prior PAP therapy, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 months

80 Participants Needed

Trial Summary

What is the purpose of this trial?

A feasibility randomized controlled trial will be conducted with a 6-month follow up to: Examine the impact of early intensive telemedicine motivational enhancement (TIME) vs standard of care on PAP adherence (n=40/group) and continuity of care at 3 and 6 months post-discharge in patients admitted with ADHF with a new inpatient diagnosis of OSA(REI\>5). Assess the effect of early telemedicine integrated with motivational enhancement (TIME) vs standard of care on patient reported outcomes including Functional Outcomes of Sleep questionnaire (FOSQ-10), Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Investigate the impact of early TIME vs standard of care on 6-month hospital readmissions.

Research Team

Cinthya Pena Orbea, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

This trial is for patients hospitalized with acute decompensated heart failure (ADHF) who are newly diagnosed with obstructive sleep apnea (OSA, REI ≥5), have not used PAP therapy before, and agree to use it. Excluded are those with central predominant apnea, unstable vital signs, dementia, prior PAP use, inability to consent or participate in video calls.

Inclusion Criteria

I am diagnosed with acute decompensated heart failure.

I have not received any treatment and agree to start PAP therapy.

I have been diagnosed with obstructive sleep apnea.

Exclusion Criteria

I have received PAP therapy before or am currently on it.

My oxygen levels drop below 87% without aid or I need more than 2L of O2 at night.

You have problems with memory and thinking.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Auto-CPAP therapy and motivational enhancement intervention or standard care

6 months

2 visits (in-person) at 2 weeks and 2 months, additional telemedicine sessions

Follow-up

Participants are monitored for PAP adherence and health outcomes, with booster sessions at 4 months

6 months

Booster phone call at 4 months

Treatment Details

Interventions

• Telemedicine Intensive Motivational Enhancement

Trial Overview The study tests if a telemedicine program providing intensive motivational support (TIME) can improve adherence to positive airway pressure (PAP) therapy over standard care. It also looks at the effect on patient outcomes and hospital readmissions within 6 months after discharge.

Participant Groups

Group I: Telemedicine Intensive Motivational Enhancement Experimental Treatment 1 Intervention

Participants will attend a telemedicine motivational enhancement visit to improve PAP adherence along with regular follow up for sleep apnea

Group II: Standard of Care with provider Active Control 1 Intervention

Participant will continue follow up for sleep apnea with provider.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

American Academy of Sleep Medicine

Collaborator

Trials

29

Recruited

3,000+