Mass Spectral Fingerprinting in Obstructive Sleep Apnoea

Obstructive Sleep Apnoea (OSA) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02810158
• Other study ID #: BASEC-Nr.2016-00384
• Status: Completed
• Start date: June 2016
• Est. completion date: May 2018

Study information

• Verified date: October 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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:

Related Conditions & MeSH terms

• Apnea
• Exhaled Breath
• Mass Spectrometry
• Obstructive Sleep Apnoea (OSA)
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Pneumology	Zurich	ZH

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OSA-specific mass spectrometric pattern of VOCs in the exhaled breath	Concentration of volatile organic compounds (VOCs) in the exhaled breath will be analysed using mass spectrometry	one hour, single measurement, no follow-up