Breath Analysis in Obstructive Sleep Apnoea

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Obstructive Sleep Apnoea (OSA)

Intervention / Treatment
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* Device: Placebo-CPAP device
* Device: CPAP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled breath pattern. | 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) | measure of sleep apnoea severity | at baseline and at follow-up (2 weeks) | 
| oxygen desaturation index (ODI), 4% dips | measure of sleep apnoea severity | at baseline and at follow-up (2 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSA, CPAP, exhaled breath