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

NCT06188247 | Completed

• 1 other identifier: 2305474
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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 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

Atrial Fibrillation; Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Drop-outs

  The primary outcome of this pilot trial is the percentage of drop-outs (defined as not completing the 12 week study period) in participants given informed consent and having received the mail-in package.

  3 months

Interventions

NightOwl home-monitoring DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead

Study Sites (1)

Herlev and Gentofte Hospital

Gentofte Municipality, Denmark

Location

Related Publications (1)

• Hashiba M, Al-Alak A, Nielsen SK, Kayser L, Nouhravesh N, Elmegaard M, El-Chouli M, Risom S, Frandsen RAV, Jennum P, Lamberts M. Feasibility of a decentralised trial of sleep apnoea screening in patients with atrial fibrillation. Dan Med J. 2025 Oct 2;72(11):A12240892. doi: 10.61409/A12240892.

  PMID: 41133329 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 3, 2024
• Study Start: December 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: January 29, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)