Obstructive Sleep Apnoea (OSA)
Conditions
Keywords
OSA, CPAP, exhaled breath
Brief summary
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
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.
Interventions
DEVICEPlacebo-CPAP device
short-term CPAP withdrawal by the use of Placebo-CPAP
DEVICECPAP
Patients continue therapeutic CPAP therapy
Sponsors
Swiss National Science Foundation
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exhaled breath pattern. | at baseline and at follow-up (2 weeks) | OSA-specific mass spectrometric exhaled breath pattern. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| apnoea-hypopnoea index (AHI) | at baseline and at follow-up (2 weeks) | measure of sleep apnoea severity |
| oxygen desaturation index (ODI), 4% dips | at baseline and at follow-up (2 weeks) | measure of sleep apnoea severity |
Countries
Switzerland
Outcome results
None listed