Clinical trial NCT06246825: the Pathophysiology of the Onset of Atrial Fibrillation in Obstructive Sleep Apnea
Official title: the Pathophysiology of the Onset of Atrial Fibrillation in Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Atrial Fibrillation
Obstructive Sleep Apnea of Adult
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited in the Cardiology department of the Catharina Hospital Eindhoven (CZE). Patients presented here are referred by general practitioners and cardiologists in neighboring hospitals (Elkerliek Helmond, St. Anna Geldrop, St Jans Gasthuis Weert, Maxima Medisch Centrum Veldhoven, Bernhoven Uden). These patients generally have a high AF burden and frequent paroxysms. Patients with frequent paroxysms are preferred, as those have the highest chance of onset of AF during the one-night PSG. A large number of patients, approximately 400 unique patients per year, visits this clinic and, based on a small sample, 38% would meet the inclusion criteria.

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


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)

Primary outcomes:
measure: Respiratory effort
timeFrame: 1 night, during the polysomnography
measure: Invasive respiratory effort
timeFrame: 1 night, during the polysomnography
measure: hypoxic burden
timeFrame: 1 night, during the polysomnography
measure: Vagal tone
timeFrame: 1 night, during the polysomnography
Secondary outcomes:
measure: Validation of diaphragm EMG
timeFrame: 1 night, during the polysomnography
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
Study officials:
affiliation: Eindhoven University of Technology / Catharina Hospital Eindhoven
name: Lukas RC Dekker, MD, PhD, prof
role: STUDY_CHAIR
References: