the Pathophysiology of the Onset of Atrial Fibrillation in Obstructive Sleep Apnea (PARABOLA)

Catharina Hospital

Status: Invitation-only

Conditions: Obstructive Sleep Apnea of Adult; Atrial Fibrillation

Treatments: Diagnostic Test: Polysomnography

Study type: Observational

Funder types: Other

Identifiers

NCT06246825

CatharinaZE_PARABOLA

Details and patient eligibility

About

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

Enrollment: 190 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

190 participants in 1 patient group

PARABOLA cohort

Description:

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

Treatment:

Diagnostic Test: Polysomnography