Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation

NCT06263608 | Recruiting

• 1 other identifier: BUN B3002023000204
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 2

Brief Summary

The main goal of this prospective pre-post implementation study is to investigate how a structured testing and treatment program for obstructive sleep apnea using the NOX T3s device and a Fitbit smartwatch with the FibriCheck algorithm impacts the proportion of atrial fibrillation (AF) in an AF population. Participants will wear the NOX T3s respiratory polygraphy device for one night at home. In case of a positive obstructive sleep apnea diagnosis, patients will be referred to the sleep clinic for a polysomnography examination. Patients positively diagnosed with polygraph will be monitored semi-continuously with the Fitbit smartwatch for three months. After the polysomnography examination, the positively diagnosed patients will be monitored semi-continuously for another three months after initiation of treatment (mostly continuous positive airway pressure (CPAP) treatment). Additionally, patients will be administered satisfaction, symptom burden and alcohol consumption questionnaires twice: right after the polysomnography examination and after the 3-month treatment.

Conditions

Atrial Fibrillation; Obstructive Sleep Apnea

Keywords

Atrial fibrillation; Obstructive sleep apnea; Cardiorespiratory polygraphy; Continuous positive airway pressure; Mobile health technology

Outcome Measures

Primary Outcomes (1)

• AF burden before and after CPAP treatment

  The AF burden will be measured via semi-continuous FibriCheck measurements via a Fitbit smartwatch.

  During the entire duration of the study (2 periods of 3 months)

Secondary Outcomes (10)

• Obstructive sleep apnea severity agreement between polygraphy and polysomnography

  Result known after polysomnography examination, on average 6 weeks after the polysomnography examination

• False positive rate of polygraphy

  Result known after polysomnography examination, on average 6 weeks after the polysomnography examination

• Total sleep apnea burden

  On average 3 months after initiation of obstructive sleep apnea treatment

• CPAP/BiPAP/ASV compliance

  On average 3 months after initiation of obstructive sleep apnea treatment

• Sleep score

  3 months after first and after second period of semi-continuous monitoring with Fitbit smartwatch

Other Outcomes (6)

• User-friendliness of the NOX T3s polygraphy device

  Right after using the polygraphy device

• User-friendliness of the Fitbit-based FibriCheck monitoring

  Right after the first and second period of 3 months of semi-continuous monitoring with the Fitbit smartwatch

• Uptake rate of the advice to patients to undergo a polysomnography examination

  Immediately after the polysomnography examination

Study Arms (1)

Symptomatic AF patients

OTHER

Eligible participants will use the NOX T3s polygraphy device for one night at home. If they have a positive obstructive sleep apnea diagnosis, they will be referred to a polysomnography examination, and subsequently treatment. Participants will also receive 3 to 6 months of semi-continuous heart rhythm monitoring with the Fitbit smartwatch (depending on whether they get treatment after obstructive sleep apnea diagnosis via polysomnography).

Device: (Cardio)Respiratory polygraphy (NOX T3s); Diagnostic Test: Polysomnography; Device: Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV); Device: Fitbit smartwatch

Interventions

(Cardio)Respiratory polygraphy (NOX T3s) DEVICE

This home-based device enables the detection of obstructive sleep apnea by calculating the apnea hypopnea index (AHI).

Symptomatic AF patients

Polysomnography DIAGNOSTIC_TEST

Polysomnography allows both sleep and respiration monitoring during an overnight stay in a dedicated sleep clinic.

Symptomatic AF patients

Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV) DEVICE

Devices can be used to deliver CPAP, BiPAP, or ASV treatment to open up the airways, making breathing during sleep possible.

Symptomatic AF patients

Fitbit smartwatch DEVICE

The smartwatch enables the semi-continuous monitoring of the heart rhythm via the installed FibriCheck algorithm.

Symptomatic AF patients

Eligibility Criteria

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

You may qualify if:

• Patients in whom AF (paroxysmal or persistent) is diagnosed with a 12-lead ECG
• Patients who experience symptoms of their AF (mEHRA ≥ 2a)
• Older than 18 years
• Owning a smartphone compatible with Fitbit and FibriCheck applications (i.e. recent versions of Apple iOS or Android drivers)
• Ability to sign the informed consent

You may not qualify if:

• Patients diagnosed with permanent AF or only atrial flutter
• Prior/recent polysomnography evaluation
• Prior/active CPAP/BiPAP/ASV treatment
• Cognitive impairment
• Inability to speak or fully understand Dutch
• Pacemaker-dependent heart rhythm

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Jessa Hospital: collaborator
• Hasselt University: collaborator
• Universiteit Antwerpen: collaborator

Study Sites (2)

University Hospital of Antwerp

Edegem, Belgium

RECRUITING

Jessa Hospital

Hasselt, Belgium

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Sleep Apnea, Obstructive

Interventions

Polysomnography; Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Hein Heidbuchel, MD, PhD

  University Hospital of Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lien Desteghe, MSc, PhD

CONTACT

+32 3 821 33 06; lien.desteghe@uza.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 16, 2024
• Study Start: February 23, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 15, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)