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COMPLETED
NCT04760002

DANish Patients With Atrial Fibrillation and Sleep Apnea Prevalence by Night Owl

Sponsor: Herlev and Gentofte Hospital

View on ClinicalTrials.gov

Summary

A project of the feasibility of using NightOwl to detect the prevalence of obstructive sleep apnea (OSA) in patients with atrial fibrillation (AF). The long-term aim is to use the device to screen for OSA in a randomized clinical trial in AF patients undergoing ablation and/or a randomized trial of AF patients undergoing cardioversion.

Official title: Danish Patients With Atrial Fibrillation and Sleep Apnea Prevalence by Night Owl

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

126

Start Date

2021-01-25

Completion Date

2023-01-01

Last Updated

2026-09-22

Healthy Volunteers

Not specified

Interventions

DEVICE

NightOwl

The NightOwl consists of a small sensor device which is placed on the fingertip and a smartphone app that is connected to an encrypted cloud-based analytics platform within the European Union, the NightOwl software. It is self-applied by attaching the sensor to the fingertip by means of an adhesive patch. The NightOwl sensor acquires accelerometer data and reflectancebased photoplethysmography (PPG) from which it derives actigraphy (sleep/wake behavior), SpO2, peripheral artery tone (PAT) and pulse rate, among other features. A PAT analysis derives changes in caliber of arteries elicited by alterations in the contractile activity of vascular smooth muscle and are referred to as changes in arterial tone. The end state of the apnea-hypopnea events are associated with sympathetic activation.

Locations (1)

Herlev-Gentofte Hospital

Copenhagen, Denmark