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Breath Analysis in Obstructive Sleep Apnoea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02050425
First Posted: January 30, 2014
Last Update Posted: November 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Malcolm Kohler, University of Zurich
  Purpose
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.

Condition Intervention
Obstructive Sleep Apnoea (OSA) Device: Placebo-CPAP device Device: CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Exhaled Breath Analysis by Mass Spectrometry in Patients With Obstructive Sleep Apnoea - a Randomised Placebo-controlled Trial.

Resource links provided by NLM:


Further study details as provided by Malcolm Kohler, University of Zurich:

Primary Outcome Measures:
  • Exhaled breath pattern. [ Time Frame: at baseline and at follow-up (2 weeks) ]
    OSA-specific mass spectrometric exhaled breath pattern.


Secondary Outcome Measures:
  • apnoea-hypopnoea index (AHI) [ Time Frame: at baseline and at follow-up (2 weeks) ]
    measure of sleep apnoea severity

  • oxygen desaturation index (ODI), 4% dips [ Time Frame: at baseline and at follow-up (2 weeks) ]
    measure of sleep apnoea severity


Estimated Enrollment: 30
Study Start Date: January 2014
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: subtherapeutic CPAP

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050425


Locations
Switzerland
Division of Pulmonology, University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Swiss National Science Foundation
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Malcolm Kohler, Prof. Dr. med., University of Zurich
ClinicalTrials.gov Identifier: NCT02050425     History of Changes
Other Study ID Numbers: KEK-2013-0536
First Submitted: January 28, 2014
First Posted: January 30, 2014
Last Update Posted: November 25, 2014
Last Verified: November 2014

Keywords provided by Malcolm Kohler, University of Zurich:
OSA
CPAP
exhaled breath

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases