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Trial record 1 of 1 for:    NCT02810158
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Mass Spectral Fingerprinting in Obstructive Sleep Apnoea

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ClinicalTrials.gov Identifier: NCT02810158
Recruitment Status : Completed
First Posted : June 22, 2016
Last Update Posted : October 19, 2018
Sponsor:
Collaborator:
Swiss Federal Institute of Technology
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date June 20, 2016
First Posted Date June 22, 2016
Last Update Posted Date October 19, 2018
Study Start Date June 2016
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 20, 2016)
OSA-specific mass spectrometric pattern of VOCs in the exhaled breath [ Time Frame: one hour, single measurement, no follow-up ]
Concentration of volatile organic compounds (VOCs) in the exhaled breath will be analysed using mass spectrometry
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02810158 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mass Spectral Fingerprinting in Obstructive Sleep Apnoea
Official Title Diagnosis of Obstructive Sleep Apnoea by Selective Secondary Electrospray Ionization - Mass Spectrometry (SESIMS)
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with clinical suspicion of OSA
Condition
  • Obstructive Sleep Apnoea (OSA)
  • Exhaled Breath
  • Mass Spectrometry
Intervention Not Provided
Study Groups/Cohorts Patients with suspected OSA
Persons with clinical suspicion of obstructive sleep apnoea syndrome (OSA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 20, 2016)
150
Original Estimated Enrollment Same as current
Actual Study Completion Date May 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02810158
Other Study ID Numbers BASEC-Nr.2016-00384
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Zurich
Study Sponsor University of Zurich
Collaborators Swiss Federal Institute of Technology
Investigators
Principal Investigator: Malcolm Kohler, Prof. MD University of Zurich
PRS Account University of Zurich
Verification Date October 2018