Mass Spectral Fingerprinting in Obstructive Sleep Apnoea

October 18, 2018 updated by: University of Zurich

Diagnosis of Obstructive Sleep Apnoea by Selective Secondary Electrospray Ionization - Mass Spectrometry (SESIMS)

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Division of Pneumology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with clinical suspicion of OSA

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with suspected OSA
Persons with clinical suspicion of obstructive sleep apnoea syndrome (OSA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one hour, single measurement, no follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

Swiss Federal Institute of Technology

Investigators

  • Principal Investigator: Malcolm Kohler, Prof. MD, University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 22, 2016

Study Record Updates

Last Update Posted (Actual)

October 19, 2018

Last Update Submitted That Met QC Criteria

October 18, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASEC-Nr.2016-00384

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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