Mass Spectral Fingerprinting in Obstructive Sleep Apnoea
Sponsor
University of Zurich (Other)
Overall Status
Completed
CT.gov ID
NCT02810158
Collaborator
Swiss Federal Institute of Technology (Other)
150
1
23
6.5
Study Details
Study Description
Brief Summary
To answer the question whether a previously detected breath profile in patients suffering from obstructive sleep apnoea (OSA) can be found in a cohort of patients with suspected OSA using mass spectrometry (validation study).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
150 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Diagnosis of Obstructive Sleep Apnoea by Selective Secondary Electrospray Ionization - Mass Spectrometry (SESIMS)
Study Start Date
:
Jun 1, 2016
Actual Primary Completion Date
:
May 1, 2018
Actual Study Completion Date
:
May 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with suspected OSA Persons with clinical suspicion of obstructive sleep apnoea syndrome (OSA) |
Outcome Measures
Primary Outcome Measures
- OSA-specific mass spectrometric pattern of VOCs in the exhaled breath [one hour, single measurement, no follow-up]
Concentration of volatile organic compounds (VOCs) in the exhaled breath will be analysed using mass spectrometry
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Clinical suspicion of obstructive sleep apnoea syndrome (based on clinical symptoms such as increased daytime sleepiness; Epworth Sleepiness Score (ESS) > 10).
-
Age between 18 and 85 years at study entry.
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Zurich, Division of Pneumology | Zurich | ZH | Switzerland | 8091 |
Sponsors and Collaborators
- University of Zurich
- Swiss Federal Institute of Technology
Investigators
- Principal Investigator: Malcolm Kohler, Prof. MD, University of Zurich
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University of Zurich
ClinicalTrials.gov Identifier:
NCT02810158
Other Study ID Numbers:
- BASEC-Nr.2016-00384
First Posted:
Jun 22, 2016
Last Update Posted:
Oct 19, 2018
Last Verified:
Oct 1, 2018