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|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2014 (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02050425
|Division of Pulmonology, University Hospital Zurich|
|Zurich, Switzerland, 8091|