Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06618417

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

Led by Herlev and Gentofte Hospital · Updated on 2025-01-17

936

Participants Needed

1

Research Sites

133 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Established diagnosis of paroxysmal or persistent atrial fibrillation
  • Ownership of a compatible smartphone or willingness to use one provided by the investigators
  • Understanding of possible sleep apnea treatment options including CPAP therapy
Not Eligible

You will not qualify if you...

  • Previous investigation for sleep-disordered breathing
  • Advanced heart failure with left ventricular dysfunction and NYHA class III or IV
  • Holding an occupational driver's license
  • Pregnancy
  • Current use of Doxazosin or Terazosin (alpha-adrenergic antagonists)
  • Peripheral arterial disease causing daily intermittent claudication

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Herlev-Gentofte Hospital

Hellerup, Denmark, 2900

Actively Recruiting

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Research Team

M

Morten Kjøbek Lamberts ML Associate Professor Lamberts

CONTACT

M

Mads Hashiba Jensen Hashiba, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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