Breath Analysis in Obstructive Sleep Apnoea

Obstructive Sleep Apnoea (OSA) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050425
• Other study ID #: KEK-2013-0536
• Status: Completed
• Phase: N/A
• First received: January 28, 2014
• Last updated: November 23, 2014
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnoea (OSA)
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Placebo-CPAP device
short-term CPAP withdrawal by the use of Placebo-CPAP
• CPAP
Patients continue therapeutic CPAP therapy

Locations

Country	Name	City	State
Switzerland	Division of Pulmonology, University Hospital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exhaled breath pattern.	OSA-specific mass spectrometric exhaled breath pattern.	at baseline and at follow-up (2 weeks)	No
Secondary	apnoea-hypopnoea index (AHI)	measure of sleep apnoea severity	at baseline and at follow-up (2 weeks)	No
Secondary	oxygen desaturation index (ODI), 4% dips	measure of sleep apnoea severity	at baseline and at follow-up (2 weeks)	No