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NCT Number: NCT02050425

Breath Analysis in Obstructive Sleep Apnoea

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.

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Key information

Conditions

Obstructive Sleep Apnoea (OSA) Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Pulmonology, University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo-CPAP device

Device

short-term CPAP withdrawal by the use of Placebo-CPAP

Other names: subtherapeutic CPAP

CPAP

Device

Patients continue therapeutic CPAP therapy

Primary outcomes

  1. Exhaled breath pattern.

    Time frame: at baseline and at follow-up (2 weeks)

    OSA-specific mass spectrometric exhaled breath pattern.

Secondary outcomes

  1. apnoea-hypopnoea index (AHI)

    Time frame: at baseline and at follow-up (2 weeks)

    measure of sleep apnoea severity

  2. oxygen desaturation index (ODI), 4% dips

    Time frame: at baseline and at follow-up (2 weeks)

    measure of sleep apnoea severity

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 30, 2014
Registry last updated
Nov 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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