75 Participants Needed

Motivational Enhancement Therapy for Heart Failure and Sleep Apnea

JA
CP
Overseen ByCinthya Pena Orbea, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Cleveland Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

CP

Cinthya Pena Orbea, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

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.
See 1 more

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.
See 4 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Telemedicine Intensive Motivational EnhancementExperimental Treatment1 Intervention
Group II: Standard of Care with providerActive Control1 Intervention

Find a Clinic Near You

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+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security