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CompletedNCT01796080Updated Dec 23, 2013

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

An interventional study of Mueller manoeuvre and Inspiratory threshold in Patients With Paroxysmal Atrial Fibrillation, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-12-23.

Sponsored by University of Zurich · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Patients With Paroxysmal Atrial Fibrillation
03

In context

Sleep Apnea, Obstructive

2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 469 are open to participants now.

This study's enrollment of 45 is below the median of 53 across 1,448 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • 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

Interventions

  • OtherMueller manoeuvre
  • OtherInspiratory threshold
  • OtherExpiratory apnoea
  • OtherSteady state normal breathing
06

What researchers measure

Primary outcomes

  1. Number of subjects with premature myocardial contractions and/or atrial fibrillation

    Time frame: 20 seconds

Secondary outcomes

  1. ECG-derived myocardial de- and repolarization times

    Time frame: 20 seconds

07

Study locations

1 site
  • University Hospital Zurich, Division of Pneumology
    Zurich, ZH 8091, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01796080
Lead sponsor
University of Zurich
Responsible party
Sponsor
First posted
Feb 21, 2013
Start date
Oct 2012
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Dec 23, 2013

Study contacts

Malcolm Kohler, Prof MD
principal investigator · University Hospital Zurich, Division of Pneumology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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