MedDataX Logo

The Effect of Simulated Obstructive Apnoea and Hypopnoea on Heart Rhythm in Patients With Paroxysmal Atrial Fibrillation

NCT ID: NCT01796080

Last Updated: 2013-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this randomised controlled cross-over study we will investigate whether intrathoracic pressure changes induced by simulated obstructive apnoea and hypopnoea trigger premature supraventricular and ventricular contractions as well as atrial fibrillation in patients with paroxysmal atrial fibrillation.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patients With Paroxysmal Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mueller manoeuvre

Mueller manoeuvre lasting for 20 seconds

Group Type ACTIVE_COMPARATOR

Mueller manoeuvre

Intervention Type OTHER

Inspiratory threshold

One continuous inspiration through an inspiratory threshold load for 20 seconds

Group Type ACTIVE_COMPARATOR

Inspiratory threshold

Intervention Type OTHER

Expiratory apnoea

Expiratory apnoea (without respiratory effort) lasting for 20 seconds

Group Type ACTIVE_COMPARATOR

Expiratory apnoea

Intervention Type OTHER

Steady state normal breathing

Steady state normal breathing for 20 seconds

Group Type SHAM_COMPARATOR

Steady state normal breathing

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mueller manoeuvre

Intervention Type OTHER

Inspiratory threshold

Intervention Type OTHER

Expiratory apnoea

Intervention Type OTHER

Steady state normal breathing

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18-75 years
* History of ECG-documented paroxysmal atrial fibrillation within the last 12 months and currently in sinus rhythm
* Informed consent

Exclusion Criteria

* Mental or physical disability precluding informed consent or compliance with the protocol
* Amiodarone or Dronedarone medication
* Previous radiofrequency ablation for atrial fibrillation
* Severe structural heart disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Malcolm Kohler, Prof MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Pneumology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Zurich, Division of Pneumology

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PAF_V1.1 (05.07.2012)

Identifier Type: -

Identifier Source: org_study_id