Atrial FibrillationPARABOLANCT06246825
the Pathophysiology of the Onset of Atrial Fibrillation in Obstructive Sleep Apnea
An observational study of Atrial Fibrillation and Obstructive Sleep Apnea of Adult, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Obstructive Sleep Apnea of Adult
- What is being tested?
- Polysomnography
- How many people
- 190 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2020to 1 Sep 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Polysomnography
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyDiagnostic test
Patients with a high likelihood of having obstructive sleep apnea will undergo a polysomnography, as recommended by the guidelines
| Study group | Role | What they receive |
|---|---|---|
| PARABOLA cohort | Patients with paroxysmal or persistent atrial fibrillation and a high likelihood of obstructive sleep apnea Receives: Diagnostic Test: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory effort
Respiratory effort is measured by thoracoabdominal respiratory inductance plethysmography belts. We will calculate the integral/area above the curve of the amount of stretch on the belt (in mV) and the duration of inspiration (in seconds).
Respiratory effort (mV*s) will be measured during baseline breathing (i.e. the awake period before sleep onset), during hazard periods (prior to onset of arrhythmia) and during control periods (same sleep stage as hazard period).
Since respiratory effort is not standardized, the respiratory effort during control and hazard periods will be compared to baseline breathing (i.e. hazard period respiratory effort / baseline respiratory effort vs. control period / baseline respiratory effort)
Measured: 1 night, during the polysomnography
Invasive respiratory effort
Invasive respiratory effort is measured by intraesophageal pressure sensor (Pes), if the patient tolerates this and can sleep with it. We will calculate the integral/area above the curve of the amount of pressure difference (in mmHg) and the duration of inspiration (in seconds).
Respiratory effort (mmHg*s) will be measured during baseline breathing (i.e. the awake period before sleep onset), during hazard periods (prior to onset of arrhythmia) and during control periods (same sleep stage as hazard period).
Since respiratory effort is not standardized, the respiratory effort during control and hazard periods will be compared to baseline breathing (i.e. hazard period respiratory effort / baseline respiratory effort vs. control period / baseline respiratory effort). Comparable to primary outcome 1
Measured: 1 night, during the polysomnography
hypoxic burden
Blood oxygen levels (SpO2) are measured transcutaneously. Hypoxic burden will be calculated by calculating the integral of time (in seconds) and SpO2 < average SpO2, as published prior. The hypoxic burden beween hazard and control periods (see outcome 1 and 2) will be compared.
Measured: 1 night, during the polysomnography
Vagal tone
The vagal tone will be assessed non-invasive through heart rate variability parameters (mainly LF/HF ratio (unitless) and RMSSD (ms^2). The heart rate variability parameters will be compared between hazard and control periods.
Measured: 1 night, during the polysomnography
Secondary outcomes (1)
Validation of diaphragm EMG
We will validate an algorithm that will try to assess the respiratory effort based of the signals of the diaphragm EMG by either using maximum amplitude (mV) or by combining the amplitude the signal (mV) with the duration (s)
Measured: 1 night, during the polysomnography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Dec 2020
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maarten van den Broek, Catharina Ziekenhuis Eindhoven
- Investigators
- Lukas RC Dekker, MD, PhD, prof, Study chair, Eindhoven University of Technology / Catharina Hospital Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246825
- Sponsor's protocol ID
- CatharinaZE_PARABOLA
- Acronym
- PARABOLA
- Status last verified
- Jan 2024
- First submitted
- 7 Dec 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonimized, full PSG data can be shared for scientific purposes only.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Pathophysiology of the Onset of Atrial Fibrillation in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06246825
- Acronym / sponsor ID
- PARABOLA / CatharinaZE_PARABOLA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PARABOLA cohort | – | Diagnostic Test: PolysomnographyPatients with paroxysmal or persistent atrial fibrillation and a high likelihood of obstructive sleep apnea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- current adequate treatment of OSA
- Reversible cause of AF
- severe lung disease (COPD Gold IV, pumonary fibrosis, lobectomy) wever esophageal disease (malignancy, stricture, esophagectomy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolysomnographyPatients with a high likelihood of having obstructive sleep apnea will undergo a polysomnography, as recommended by the guidelines | Diagnostic test | PARABOLA cohort |
Primary outcome
Respiratory effort
Time frame: 1 night, during the polysomnography
Respiratory effort is measured by thoracoabdominal respiratory inductance plethysmography belts. We will calculate the integral/area above the curve of the amount of stretch on the belt (in mV) and the duration of inspiration (in seconds). Respiratory effort (mV*s) will be measured during baseline breathing (i.e. the awake period before sleep onset), during hazard periods (prior to onset of arrhythmia) and during control periods (same sleep stage as hazard period). Since respiratory effort is not standardized, the respiratory effort during control and hazard periods will be compared to baseline breathing (i.e. hazard period respiratory effort / baseline respiratory effort vs. control period / baseline respiratory effort)
Invasive respiratory effort
Time frame: 1 night, during the polysomnography
Invasive respiratory effort is measured by intraesophageal pressure sensor (Pes), if the patient tolerates this and can sleep with it. We will calculate the integral/area above the curve of the amount of pressure difference (in mmHg) and the duration of inspiration (in seconds). Respiratory effort (mmHg*s) will be measured during baseline breathing (i.e. the awake period before sleep onset), during hazard periods (prior to onset of arrhythmia) and during control periods (same sleep stage as hazard period). Since respiratory effort is not standardized, the respiratory effort during control and hazard periods will be compared to baseline breathing (i.e. hazard period respiratory effort / baseline respiratory effort vs. control period / baseline respiratory effort). Comparable to primary outcome 1
hypoxic burden
Time frame: 1 night, during the polysomnography
Blood oxygen levels (SpO2) are measured transcutaneously. Hypoxic burden will be calculated by calculating the integral of time (in seconds) and SpO2 < average SpO2, as published prior. The hypoxic burden beween hazard and control periods (see outcome 1 and 2) will be compared.
Vagal tone
Time frame: 1 night, during the polysomnography
The vagal tone will be assessed non-invasive through heart rate variability parameters (mainly LF/HF ratio (unitless) and RMSSD (ms^2). The heart rate variability parameters will be compared between hazard and control periods.
1 secondary outcome
Validation of diaphragm EMG
Time frame: 1 night, during the polysomnography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: Yes. Anonimized, full PSG data can be shared for scientific purposes only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukas RC Dekker, MD, PhD, prof study chair
Eindhoven University of Technology / Catharina Hospital Eindhoven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Obstructive Sleep Apnea of Adult, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory effort (time frame: 1 night, during the polysomnography). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.