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

December 20, 2013 updated by: University of Zurich
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Division of Pneumology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mueller manoeuvre
Mueller manoeuvre lasting for 20 seconds
Other: Mueller manoeuvre
Active Comparator: Inspiratory threshold
One continuous inspiration through an inspiratory threshold load for 20 seconds
Other: Inspiratory threshold
Active Comparator: Expiratory apnoea
Expiratory apnoea (without respiratory effort) lasting for 20 seconds
Other: Expiratory apnoea
Sham Comparator: Steady state normal breathing
Steady state normal breathing for 20 seconds
Other: Steady state normal breathing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with premature myocardial contractions and/or atrial fibrillation
Time Frame: 20 seconds
20 seconds

Secondary Outcome Measures

Outcome Measure
Time Frame
ECG-derived myocardial de- and repolarization times
Time Frame: 20 seconds
20 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 18, 2013

First Submitted That Met QC Criteria

February 18, 2013

First Posted (Estimate)

February 21, 2013

Study Record Updates

Last Update Posted (Estimate)

December 23, 2013

Last Update Submitted That Met QC Criteria

December 20, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAF_V1.1 (05.07.2012)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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