Breath Analysis in Obstructive Sleep Apnoea

University of Zurich (UZH)

Status: Completed

Conditions: Obstructive Sleep Apnoea (OSA)

Treatments: Device: Placebo-CPAP device; Device: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT02050425

KEK-2013-0536

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Therapeutic CPAP

Active Comparator group

Description:

Patients continue therapeutic continuous positive airway pressure (CPAP).

Treatment:

Device: CPAP

Subtherapeutic CPAP

Placebo Comparator group

Description:

Placebo-CPAP device delivering subtherapeutic pressure for two weeks.

Treatment:

Device: Placebo-CPAP device