Breath Analysis in Obstructive Sleep Apnoea
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02050425|
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : November 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnoea (OSA)||Device: Placebo-CPAP device Device: CPAP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Exhaled Breath Analysis by Mass Spectrometry in Patients With Obstructive Sleep Apnoea - a Randomised Placebo-controlled Trial.|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
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
- Exhaled breath pattern. [ Time Frame: at baseline and at follow-up (2 weeks) ]OSA-specific mass spectrometric exhaled breath pattern.
- apnoea-hypopnoea index (AHI) [ Time Frame: at baseline and at follow-up (2 weeks) ]measure of sleep apnoea severity
- oxygen desaturation index (ODI), 4% dips [ Time Frame: at baseline and at follow-up (2 weeks) ]measure of sleep apnoea severity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050425
|Division of Pulmonology, University Hospital Zurich|
|Zurich, Switzerland, 8091|