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NCT06246825: PARABOLA

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

Status unknown Last updated 7 February 2024
What this trial tests

trial testing Polysomnography in Atrial Fibrillation in 190 participants. Status unknown.

Timeline
1 December 2020
Primary endpoint
1 February 2024
1 September 2024

Quick facts

Lead sponsorCatharina Ziekenhuis Eindhoven
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment190
Start date1 December 2020
Primary completion1 February 2024
Estimated completion1 September 2024
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Catharina Ziekenhuis Eindhoven — full company profile →

Who can join

18 and older, any sex, with Atrial Fibrillation or Obstructive Sleep Apnea of Adult. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Obstructive sleep apnea screening performance of the STOP-BANG questionnaire and a home sleep apnea test device in atrial fibrillation ablation candidates.
    Vermeer J, van den Broek M, Vinck-de Greef T, Janssen H, et al · · 2026 · PMID 41108480 · DOI 10.1007/s10840-025-02131-7

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Other trials of Polysomnography

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Data sources for this page

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