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Motivational Enhancement Therapy for Heart Failure and Sleep Apnea

N/A
Recruiting
Led By Cinthya Pena Orbea, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Admitting ADHF diagnosis
Treatment-naive and agreeable to PAP therapy
Must not have
Prior or current PAP therapy
Moderately hypoxic (oxygen saturation < 87% on room air or requiring >2L of O2 during overnight sleep study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the effects of two different methods of care on patients with a new diagnosis of OSA who have been admitted to the hospital for ADHF. One group of patients will receive standard care, while the other group will receive early telemedicine care that includes motivational enhancement. The trial will follow patients for six months to assess the impact of the different methods of care on things like patient reported outcomes, hospital readmissions, and continuity of care.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While this trial focuses on behavioral intervention rather than medication side effects may include discomfort from using PAP devices or potential stress from frequent telemedicine sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am diagnosed with acute decompensated heart failure.
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I have not received any treatment and agree to start PAP therapy.
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I have been diagnosed with obstructive sleep apnea.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received PAP therapy before or am currently on it.
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My oxygen levels drop below 87% without aid or I need more than 2L of O2 at night.
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I am unable to understand and agree to the study's details on my own.
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I do not have low blood pressure (<90 mmHg) or a fast heart rate (>120 bpm).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Functional Outcomes of Sleep Questionnaire (TIME versus Standard of Care)
Kansas City Cardiomyopathy Questionnaire (TIME versus Standard of Care)
PAP Adherence (TIME versus Standard of Care)
Other study objectives
Impact of TIME vs Standard of Care on 6-month hospital readmissions

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Telemedicine Intensive Motivational EnhancementExperimental Treatment1 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 providerActive Control1 Intervention
Participant will continue follow up for sleep apnea with provider.

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,057 Previous Clinical Trials
1,371,680 Total Patients Enrolled
American Academy of Sleep MedicineOTHER
25 Previous Clinical Trials
2,810 Total Patients Enrolled
Cinthya Pena Orbea, MDPrincipal Investigator - The Cleveland Clinic
The Cleveland Clinic

Media Library

Telemedicine Intensive Motivational Enhancement Clinical Trial Eligibility Overview. Trial Name: NCT04752462 — N/A
Motivational Enhancement Therapy Research Study Groups: Standard of Care with provider, Telemedicine Intensive Motivational Enhancement
Motivational Enhancement Therapy Clinical Trial 2023: Telemedicine Intensive Motivational Enhancement Highlights & Side Effects. Trial Name: NCT04752462 — N/A
Telemedicine Intensive Motivational Enhancement 2023 Treatment Timeline for Medical Study. Trial Name: NCT04752462 — N/A
~0 spots leftby Dec 2024
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