National Decentral/Virtual Randomized Trial Testing Remote Sleep Apnea Evaluation in Patients with Atrial Fibrillation

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to find out if testing for sleep apnea (a condition where breathing stops and starts during sleep) at home can improve well-being in people with atrial fibrillation (an irregular heartbeat condition). About 936 participants will be involved. They will either be tested for sleep apnea and treated, if needed, or not tested at all. Researchers will compare the well-being and heart-related symptoms of participants who are tested for sleep apnea to those who are not. These will be tracked using a mobile app to monitor symptoms, physical activity, and heart rhythm. Main hypothesis: Participants with atrial fibrillation who are tested and possibly treated for sleep apnea will have improved quality of life scores (measured by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire) by at least 5 points after 18 weeks.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Established paroxysmal or persistent AF diagnosis

• Owning a compatible smartphone (or accepting a smart phone provided by the investigators)

• Understanding of potential SA treatment possibilities including CPAP treatment

Locations
Other Locations
Denmark
Herlev-Gentofte Hospital
RECRUITING
Hellerup
Contact Information
Primary
Morten Kjøbek Lamberts ML Associate Professor Lamberts
morten.kjoebek.lamberts@regionh.dk
+45 22434186
Backup
Mads Hashiba Jensen Hashiba, MD
mads.hashiba.jensen.01@regionh.dk
+45 28779403
Time Frame
Start Date: 2024-12-05
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 936
Treatments
Experimental: Intervention
The intervention will be sleep apnea home-evaluation
No_intervention: Control
This arm will not undergo sleep apnea home-evaluation
Related Therapeutic Areas
Sponsors
Leads: Herlev and Gentofte Hospital

This content was sourced from clinicaltrials.gov