Breath Analysis in Obstructive Sleep Apnoea
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Exhaled Breath Analysis by Mass Spectrometry in Patients With Obstructive Sleep Apnoea - a Randomised Placebo-controlled Trial.|
- Exhaled breath pattern. [ Time Frame: at baseline and at follow-up (2 weeks) ] [ Designated as safety issue: No ]OSA-specific mass spectrometric exhaled breath pattern.
- apnoea-hypopnoea index (AHI) [ Time Frame: at baseline and at follow-up (2 weeks) ] [ Designated as safety issue: No ]measure of sleep apnoea severity
- oxygen desaturation index (ODI), 4% dips [ Time Frame: at baseline and at follow-up (2 weeks) ] [ Designated as safety issue: No ]measure of sleep apnoea severity
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Therapeutic CPAP
Patients continue therapeutic continuous positive airway pressure (CPAP).
Patients continue therapeutic CPAP therapy
Placebo Comparator: Subtherapeutic CPAP
Placebo-CPAP device delivering subtherapeutic pressure for two weeks.
Device: Placebo-CPAP device
short-term CPAP withdrawal by the use of Placebo-CPAP
Other Name: subtherapeutic CPAP
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.
|Contact: Malcolm Kohler, Prof. MDfirstname.lastname@example.org|
|Contact: Esther I Schwarz, MDemail@example.com|
|Division of Pulmonology, University Hospital Zurich||Recruiting|
|Zurich, Switzerland, 8091|
|Contact: Malcolm Kohler, Prof. MD +4144255111 firstname.lastname@example.org|
|Contact: Esther I Schwarz, MD +4144255111 email@example.com|
|Principal Investigator: Malcolm Kohler, Prof. MD|
|Sub-Investigator: Esther I Schwarz, MD|