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Search / Trial NCT04752462

Motivational Enhancement - Acute Decompensated Heart Failure and OSA

Launched by THE CLEVELAND CLINIC · Feb 9, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how a program called Telemedicine Motivational Enhancement (TIME) can help patients with heart failure and sleep apnea stick to their prescribed therapy using a device called CPAP (Continuous Positive Airway Pressure). Researchers want to see if this program, which offers support and encouragement through telemedicine (video calls), can improve how well patients follow their treatment compared to standard care. They will follow participants for six months to assess their health and well-being, including how well they sleep and their overall heart health, as well as whether they need to return to the hospital.

To participate in this trial, you need to be between 65 and 74 years old and have been diagnosed with acute decompensated heart failure and obstructive sleep apnea. You should not have received any previous CPAP treatment and should be willing to try it for the first time. Participants will have regular check-ins through video calls and will be asked to provide feedback on their experiences. This trial is currently recruiting participants, and your involvement could help improve care for others with similar health issues.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Admitting ADHF diagnosis
  • OSA diagnosis (REI ≥5)
  • Treatment-naive and agreeable to PAP therapy
  • Agrees to participate.
  • Exclusion Criteria:
  • Prior or current PAP therapy
  • Unable to provide informed consent
  • Moderately hypoxic (oxygen saturation \< 87% on room air or requiring \>2L of O2 during overnight sleep study
  • Hemodynamically unstable (systolic blood pressure, SBP\<90 mmHg, heart rate\>120bpm)
  • Central predominant apnea (Central Apnea Index \> 50% of the Apnea Index) Dementia/cognitive dysfunction
  • Unable to participant in video televisits.

About The Cleveland Clinic

The Cleveland Clinic is a renowned nonprofit academic medical center based in Cleveland, Ohio, recognized for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, the Cleveland Clinic leverages its multidisciplinary expertise and state-of-the-art facilities to conduct groundbreaking studies aimed at improving patient outcomes across a wide range of medical conditions. With a strong emphasis on patient-centered care, the institution fosters collaboration among researchers, clinicians, and patients to explore new treatments and therapies, contributing significantly to the global body of medical knowledge.

Locations

Cleveland, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Cinthya Pena Orbea, MD

Principal Investigator

The Cleveland Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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