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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

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
Obstructive Sleep Apnoea (OSA) Exhaled Breath Mass Spectrometry

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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 : June 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with clinical suspicion of OSA
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

Information from the National Library of Medicine

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): NCT02810158


Locations
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Switzerland
University Hospital Zurich, Division of Pneumology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Swiss Federal Institute of Technology
Investigators
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Principal Investigator: Malcolm Kohler, Prof. MD University of Zurich

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02810158     History of Changes
Other Study ID Numbers: BASEC-Nr.2016-00384
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases