Breath Analysis in Obstructive Sleep Apnoea

November 23, 2014 updated by: Malcolm Kohler, University of Zurich

Exhaled Breath Analysis by Mass Spectrometry in Patients With Obstructive Sleep Apnoea - a Randomised Placebo-controlled Trial.

Clinical trial in patients with obstructive sleep apnoea that are randomised to either continue or withdraw continuous positive airway pressure therapy to identify a disease-specific exhaled breath pattern by mass spectrometry.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomised placebo-controlled trial (therapeutic vs. subtherapeutic continuous positive airway pressure [CPAP]) including 30 OSA patients to define the effects of CPAP withdrawal (subtherapeutic CPAP) on the composition of exhaled breath analysed by mass spectrometry for identification of OSA specific markers.

Study Type

Interventional

Enrollment (Anticipated)

30

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
      • Zurich, Switzerland, 8091
        • Division of Pulmonology, University Hospital Zurich

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

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI) of >20/h.
  • Currently >20/h oxygen desaturations (≥4% dips) during an ambulatory nocturnal pulse oximetry performed on the last night of a 4-night period without CPAP.
  • Treated with CPAP for more than 12 months, minimum compliance 4h/night, apnoea-hypopnoea index (AHI) <10 with treatment (according to CPAP- download) and current ESS <10.
  • Age between 20 and 75 years at trial entry.

Exclusion Criteria:

  • Previous ventilatory failure (awake SpO2 <93% and PaCO2>6kPa).
  • Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension or hypotension (>180/110 or <90/60mmHg)
  • Previously diagnosed with Cheyne-Stokes breathing.
  • Current professional driver; any previous sleep related accident.
  • Acute inflammatory disease.
  • Acute or chronic hepatic disease.
  • Renal failure or renal replacement therapy.
  • Use of inhaled drugs.

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Therapeutic CPAP
Patients continue therapeutic continuous positive airway pressure (CPAP).
Device: CPAP
Patients continue therapeutic CPAP therapy
Placebo Comparator: Subtherapeutic CPAP
Placebo-CPAP device delivering subtherapeutic pressure for two weeks.
Device: Placebo-CPAP device
short-term CPAP withdrawal by the use of Placebo-CPAP
Other Names:
  • subtherapeutic CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exhaled breath pattern.
Time Frame: at baseline and at follow-up (2 weeks)
OSA-specific mass spectrometric exhaled breath pattern.
at baseline and at follow-up (2 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
apnoea-hypopnoea index (AHI)
Time Frame: at baseline and at follow-up (2 weeks)
measure of sleep apnoea severity
at baseline and at follow-up (2 weeks)
oxygen desaturation index (ODI), 4% dips
Time Frame: at baseline and at follow-up (2 weeks)
measure of sleep apnoea severity
at baseline and at follow-up (2 weeks)

Collaborators and Investigators

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

Sponsor

University of Zurich

Collaborators

Swiss National Science Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (Estimate)

January 30, 2014

Study Record Updates

Last Update Posted (Estimate)

November 25, 2014

Last Update Submitted That Met QC Criteria

November 23, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-2013-0536

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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