The primary objective is to assess the role of obstructive sleep apnea related pathophysiological mechanisms in the initiation of atrial fibrillation by a multi-parametric strategy that combines the estimated parameters. The main hypothesis is that…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Sleep disturbances (incl subtypes)
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Identification of prognostic factors for the initiation of atrial fibrillation
in relation to obstructive sleep apnea related pathophysiological mechanisms.
Secondary outcome
Validation of nonobtrusive photoplethysmography and diafragm electromyography
measurements as surrogate for invasive esophageal pressure measurement.
Background summary
Obstructive sleep apnea is a highly prevalent, often undiagnosed, modifiable
risk factor for atrial fibrillation, as well as atrial fibrillation related
complications and treatment effectiveness. It is unclear which obstructive
sleep apnea 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.
Study objective
The primary objective is to assess the role of obstructive sleep apnea related
pathophysiological mechanisms in the initiation of atrial fibrillation 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 and diaphragm electromyography
measurements as surrogates for gold standard technology based on invasive
intraoesophageal pressure measurement.
Study design
An observational study in a selected cohort. Subjects are recruited from the
atrial fibrillation outpatient clinic of the Catharina Hospital, and referred
to Kempenhaeghe Centre for Sleep Medicine for a one-night full polysomnography,
with the addition of diaphragm electromyography and photoplethysmography. The
acquired data will be analysed at the Eindhoven Technical University with the
aid of Philips.
Study burden and risks
Screening for obstructive sleep apnea in the atrial fibrillation population is
according to the European guidelines, and polysomnography is the gold standard
in diagnosing obstructive sleep apnea. The burden and risks associated with
participation are few; intraesophageal pressure measurement is the only added
burden that could be associated with participation. Although intraesophageal
pressure measurement is a part of the regular clinical practice and the gold
standard for the measurement of respiratory effort, in daily practice however
it is often omitted for various reasons such as cost-perspective, sufficient
diagnostic accuracy based on other measurements of respiratory effort or
patient comfort. However severe complications are very rare, and no
contemporary literature on such complications is published. Minor discomfort
might be present, and if needed the intraesophageal catheter can be removed and
the polysomnography will be conducted without. As both obstructive sleep apnea
and atrial fibrillation are very common, there is a large group that can
benefit from the results of this study. The results of this study could create
new insights to the treatment of atrial fibrillation and screening for
obstructive sleep apnea.
Michelangelolaan 2
Eindhoven 5623EJ
NL
Michelangelolaan 2
Eindhoven 5623EJ
NL
Listed location countries
Age
Inclusion criteria
Paroxysmal AF, with symptoms occurring at least once per week
STOP-BANG score >=5 or STOP-BANG >=4 and typical nocturnal onset of AF
Ability to provide informed consent
Exclusion criteria
Current (not prior) adequate (i.e. residual AHI <5) treatment with CPAP or MRA
Reversible cause of AF (e.g. hyperthyroidism)
Severe lung disease (COPD Gold IV, pulmonary fibrosis, lobectomy)
Severe esophageal disease (malignancy, stricture, esophagectomy)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL73913.100.20 |