the Pathophysiology of the Onset of Atrial Fibrillation in Obstructive Sleep Apnea

NCT ID: NCT06246825

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 190 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2024-09-01

Brief Summary

Rationale: Obstructive sleep apnea (OSA) is a highly prevalent, often undiagnosed, modifiable risk factor for atrial fibrillation (AF), as well as AF-related complications and treatment effectiveness. It is unclear which OSA-related pathophysiological mechanism, i.e. intrathoracic pressure shifts, hypoxemia or sympathovagal imbalance, plays the most dominant role, and a better understanding of these mechanisms could provide valuable information in future diagnostic and therapeutic strategies in this population. Objective: The primary objective is to assess the role of OSA-related pathophysiological mechanisms in the initiation of AF by a multi-parametric strategy that combines the estimated parameters. The main hypothesis is that intrathoracic pressure fluctuations are the predominant mechanism. The secondary objective is to validate a nonobtrusive sensing technology based on photoplethysmography (PPG) and diaphragm electromyography (dEMG) measurements as surrogates for gold standard technology based on invasive intraoesophageal pressure (PES) measurement. Study population: Adult patients with paroxysmal AF with nocturnal onset and high risk of OSA based on the STOP-BANG questionnaire. Study design: An observational study in a selected cohort. Subjects are recruited from the AF outpatient clinic of the Catharina Hospital, and referred to Kempenhaeghe Centre for Sleep Medicine for a one-night full PSG, with the addition of dEMG and PPG. The acquired data will be analysed at the Eindhoven Technical University. Main study parameters/endpoints: Primary endpoint: Identification of prognostic factors for the initiation of AF in relation to OSA-related pathophysiological mechanisms..nl

Conditions

Atrial Fibrillation; Obstructive Sleep Apnea of Adult

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PARABOLA cohort

Patients with paroxysmal or persistent atrial fibrillation and a high likelihood of obstructive sleep apnea

Polysomnography

Intervention Type: DIAGNOSTIC_TEST

Patients with a high likelihood of having obstructive sleep apnea will undergo a polysomnography, as recommended by the guidelines

Interventions

Polysomnography

Patients with a high likelihood of having obstructive sleep apnea will undergo a polysomnography, as recommended by the guidelines

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

Paroxysmal or persistent AF

AND

• STOP-BANG score >5 or STOP-BANG >4 and typical nocturnal onset of AF
• A positive WATCH-PAT screening
• very high clinical suspicion of OSA, with STOP-BANG score >3

Exclusion Criteria

• current adequate treatment of OSA
• Reversible cause of AF
• severe lung disease (COPD Gold IV, pumonary fibrosis, lobectomy) wever esophageal disease (malignancy, stricture, esophagectomy)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: lead

Responsible Party

Maarten van den Broek

Mr JLPM van den Broek, MD, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lukas RC Dekker, MD, PhD, prof

Role: STUDY_CHAIR

Eindhoven University of Technology / Catharina Hospital Eindhoven

Locations

Catharina Ziekenhuis

Eindhoven, , Netherlands

Countries

Netherlands

Other Identifiers

CatharinaZE_PARABOLA

Identifier Type: -

Identifier Source: org_study_id