NCT02810158

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

October 19, 2018

Status Verified

October 1, 2018

Enrollment Period

1.9 years

First QC Date

June 20, 2016

Last Update Submit

October 18, 2018

Conditions

Obstructive Sleep Apnoea (OSA)Exhaled BreathMass Spectrometry

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patients with suspected OSA

Persons with clinical suspicion of obstructive sleep apnoea syndrome (OSA)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with clinical suspicion of OSA

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Division of Pneumology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Nowak N, Engler A, Thiel S, Stoberl AS, Sinues P, Zenobi R, Kohler M. Validation of breath biomarkers for obstructive sleep apnea. Sleep Med. 2021 Sep;85:75-86. doi: 10.1016/j.sleep.2021.06.040. Epub 2021 Jul 3.

    PMID: 34280868DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Malcolm Kohler, Prof. MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 22, 2016

Study Start

June 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

October 19, 2018

Record last verified: 2018-10

Locations

CH(1)