Breath Analysis in Obstructive Sleep Apnoea

N/ACompletedNCT02050425

University of Zurich30 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

Conditions

Obstructive Sleep Apnoea (OSA)

Interventions

Placebo-CPAP deviceDEVICE

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

CPAPDEVICE

Patients continue therapeutic CPAP therapy

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Division of Pulmonology, University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Outcomes

Primary Outcomes

Exhaled breath pattern.

OSA-specific mass spectrometric exhaled breath pattern.

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

Secondary Outcomes

apnoea-hypopnoea index (AHI)

measure of sleep apnoea severity

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

oxygen desaturation index (ODI), 4% dips

measure of sleep apnoea severity

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

Data from ClinicalTrials.gov

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