Status:

COMPLETED

Pilot-trial Testing Remote Sleep Apnea Evaluation in Patients with Atrial Fibrillation

Lead Sponsor:

Herlev and Gentofte Hospital

Conditions:

Atrial Fibrillation

Sleep Apnea

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This is an investigator-initiated virtual (or decentralized) trial that includes a postal parcel (mail-in) containing sensors for SA diagnosis (NightOwl™) and physical activity (SENS Motion), in addit...

Detailed Description

Objectives The main aim of the pilot trial is in a completely decentralized/virtual setting to evaluate whether SA home-evaluation, physical tracking by a home-monitoring device and heart rhythm monit...

Eligibility Criteria

Inclusion

  • Age\>18 years
  • 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

Exclusion

  • Previous investigation for sleep-disturbed breathing
  • Advanced heart failure (left ventricular dysfunction and NYHA III/IV)
  • Occupational driver licenses
  • Pregnancy
  • Doxazosin or Terazosin (alpha-adrenergic antagonists)
  • Peripheral arterial disease with daily intermittent claudication

Key Trial Info

Start Date :

December 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2024

Estimated Enrollment :

25 Patients enrolled

Trial Details

Trial ID

NCT06188247

Start Date

December 1 2023

End Date

August 1 2024

Last Update

January 29 2025

Active Locations (1)

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Herlev and Gentofte Hospital

Gentofte Municipality, Denmark