About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Established paroxysmal or persistent AF diagnosis
Owning a compatible smartphone
18 years or older
Disqualifiers
Previous investigation for sleep-disturbed breathing
Advanced heart failure (left ventricular dysfunction and NYHA III/IV)
Occupational driver licenses
Pregnancy
Trial design
Parallel
Treatments tested in this trial
sleep apnea home-evaluation
DeviceParticipants will receive a home-monitoring device by mail to test for sleep apnea at home
Treatment groups
Trial outcomes
Primary outcomes
Quality of Life
The primary outcome is the Atrial Fibrillation Effect on Quality-Of-Life (AFEQT) questionnaire, which scores from 0 (worst) to 100 (best), based on 20 questions using a seven-point Likert scale.
Secondary outcomes
AF load
AF load by heart rhythm measurement using Fibricheck. The solution is based on a validated algorithm following patients holding their index finger on their smartphone camera during one minute. Participants will be asked for heart rhythm measurements morning, evening and in case of AF symptoms.
Physical health behavior
Physical activity will be measured by a tri-axial accelerometer (SENS Motion) worn at the lateral of the thigh for 7 days. From the accelerometer data time spent physical inactive (minutes/day) will be calculated
Symptom severity
AF severity scale (AFSS) questionnaire. AFSS is focused on AF symptoms and captures subjective and objective ratings of AF related symptoms, health care utilization, and AF disease burden. The questionnaire scores from 0 (best) to 35 (worst).
Other outcomes
Hospitalization and ablation
Long-term AF hospitalization and ablation following linkage with health registers.
Sleep quality
Pittsburgh Sleep Quality Index (PSQI) to distinguish good and poor sleepers. The questionnaire\'s global score range from 0 (best) to 21 (worst).
Quality of Life - Long-term follow up
One year after randomization, participants will complete the Atrial Fibrillation Effect On Quality-Of-Life (AFEQT) questionnaire again to assess the long-term effects of home-based sleep apnea evaluation. The score ranges from 0 (worst) to 100 (best).
Digital Health literacy
The eHealth Literacy Questionnaire (eHLQ) to assess digital health literacy before and after the study to measure potential changes. Scores is calculated as a mean from the 7 different dimensions in the questionnaire. The score ranges from 1 to 4 with higher values indicating better eHealth literacy.
Sponsors and contacts
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