Evaluating the Impact of Home-Based Sleep Apnea Diagnostic on Well-Being, Health Behavior, and AF Load in Patients With Atrial Fibrillation Using a Decentralized Platform

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHerlev and Gentofte Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • sleep apnea home-evaluation

    Device

    Participants will receive a home-monitoring device by mail to test for sleep apnea at home

Treatment groups

936 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
18 weeks

Secondary outcomes

1

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.

Time frame
18 weeks
2

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

Time frame
18 weeks
3

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).

Time frame
18 weeks

Other outcomes

1

Hospitalization and ablation

Long-term AF hospitalization and ablation following linkage with health registers.

Time frame
5 years
2

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).

Time frame
18 weeks
3

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).

Time frame
One year
4

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.

Time frame
18 weeks

Sponsors and contacts

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