Clinical trial NCT02050425: Breath Analysis in Obstructive Sleep Apnoea
Official title: Exhaled Breath Analysis by Mass Spectrometry in Patients With Obstructive Sleep Apnoea - a Randomised Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnoea (OSA)
Keywords: OSA
CPAP
exhaled breath
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2014-01-30
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: Exhaled breath pattern.
timeFrame: at baseline and at follow-up (2 weeks)
Secondary outcomes:
measure: apnoea-hypopnoea index (AHI)
timeFrame: at baseline and at follow-up (2 weeks)
measure: oxygen desaturation index (ODI), 4% dips
timeFrame: at baseline and at follow-up (2 weeks)
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Division of Pulmonology, University Hospital Zurich
Study officials:
References:
citation: Thiel S, Haile SR, Peitzsch M, Schwarz EI, Sievi NA, Kurth S, Beuschlein F, Kohler M, Gaisl T. Endocrine responses during CPAP withdrawal in obstructive sleep apnoea: data from two randomised controlled trials. Thorax. 2019 Nov;74(11):1102-1105. doi: 10.1136/thoraxjnl-2019-213522. Epub 2019 Aug 29.
citation: Stoberl AS, Schwarz EI, Haile SR, Turnbull CD, Rossi VA, Stradling JR, Kohler M. Night-to-night variability of obstructive sleep apnea. J Sleep Res. 2017 Dec;26(6):782-788. doi: 10.1111/jsr.12558. Epub 2017 May 26.
citation: Schwarz EI, Martinez-Lozano Sinues P, Bregy L, Gaisl T, Garcia Gomez D, Gaugg MT, Suter Y, Stebler N, Nussbaumer-Ochsner Y, Bloch KE, Stradling JR, Zenobi R, Kohler M. Effects of CPAP therapy withdrawal on exhaled breath pattern in obstructive sleep apnoea. Thorax. 2016 Feb;71(2):110-7. doi: 10.1136/thoraxjnl-2015-207597. Epub 2015 Dec 15.