Motivational Enhancement Therapy for Heart Failure and Sleep Apnea
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a new telemedicine approach, called Telemedicine Intensive Motivational Enhancement (TIME), can improve adherence to sleep apnea treatment compared to traditional doctor visits. It targets individuals recently diagnosed with both heart failure and sleep apnea. The study aims to determine if this approach improves sleep and heart health and reduces hospital visits. It suits those with heart failure who are new to sleep apnea treatment and willing to use a PAP machine, which helps keep airways open during sleep. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance treatment options for patients with heart failure and sleep apnea.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this telemedicine motivational enhancement is safe for heart failure and sleep apnea patients?
Research has shown that using telemedicine to boost motivation is generally well-received. Studies suggest this method can help people adhere to their sleep apnea treatment after hospital discharge. Few reports of serious side effects suggest it is safe for most patients. The trial is currently focused on evaluating the treatment's effectiveness rather than just its safety. This indicates the treatment is considered safe enough to test its effectiveness, which may reassure those considering joining the trial.12345
Why are researchers excited about this trial?
Researchers are excited about the Telemedicine Intensive Motivational Enhancement for heart failure and sleep apnea because it offers a fresh approach to improving patient adherence to positive airway pressure (PAP) therapy. Unlike the standard of care that typically involves in-person visits, this treatment leverages telemedicine to provide motivational support remotely. This approach not only increases accessibility for patients who may find regular doctor visits challenging but also aims to boost adherence to PAP therapy, which is crucial for managing sleep apnea effectively. By enhancing patient motivation through remote support, researchers hope this method will lead to better health outcomes and improved quality of life for patients.
What evidence suggests that Telemedicine Intensive Motivational Enhancement is effective for heart failure and sleep apnea?
Research has shown that Telemedicine Intensive Motivational Enhancement (TIME), which participants in this trial may receive, helps people with heart failure and sleep apnea follow their treatment plans more effectively. Studies have found that those using TIME are more likely to continue using their Positive Airway Pressure (PAP) machines after leaving the hospital, which is crucial for managing sleep apnea. This method can also improve heart health. Additionally, starting TIME early has been linked to better patient-reported outcomes, such as improved sleep quality and overall well-being. This makes TIME a promising option for people dealing with both heart failure and sleep apnea. Participants in this trial will either receive TIME or continue with standard care, which involves regular follow-up for sleep apnea with their provider.14678
Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Auto-CPAP therapy and motivational enhancement intervention or standard care
Follow-up
Participants are monitored for PAP adherence and health outcomes, with booster sessions at 4 months
What Are the Treatments Tested in This Trial?
Interventions
- Telemedicine Intensive Motivational Enhancement
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor
American Academy of Sleep Medicine
Collaborator