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

NCT06188247 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-01-29

No results posted yet for this study

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 addition to smart-phone based heart rhythm (FibriCheck) monitoring in participants with paroxysmal or persistent AF. A case-coordinator (the investigators) will manage all participant contacts virtually during the study from inclusion to follow-up.

Conditions

Interventions

DEVICE

NightOwl home-monitoring

The NightOwl™ system 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. The sensor is self-applied by attaching the sensor to the fingertip by means of an adhesive patch. The NightOwl™ sensor acquires accelerometer data and reflectance-based 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.

Sponsors & Collaborators

  • Herlev and Gentofte Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-07-01
Completion
2024-08-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06188247 on ClinicalTrials.gov