Status:
COMPLETED
Motivational Enhancement - Acute Decompensated Heart Failure and OSA
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
American Academy of Sleep Medicine
Conditions:
Acute Decompensated Heart Failure
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 a...
Detailed Description
As part of our inpatient sleep testing program, high-risk HF patients undergo Type III sleep testing (Nihon Kohden®) set up by sleep laboratory technicians. Our inpatient sleep service also has a clin...
Eligibility Criteria
Inclusion
- Admitting ADHF diagnosis
- OSA diagnosis (REI ≥5)
- Treatment-naive and agreeable to PAP therapy
- Agrees to participate.
Exclusion
- 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.
Key Trial Info
Start Date :
May 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04752462
Start Date
May 13 2021
End Date
January 31 2025
Last Update
July 9 2025
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195