Obstructive Sleep Apnoea (OSA)NCT02810158
Mass Spectral Fingerprinting in Obstructive Sleep Apnoea
An observational study of Obstructive Sleep Apnoea (OSA) and Exhaled Breath, run by University of Zurich at 1 site in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Obstructive Sleep Apnoea (OSA), Exhaled Breath, Mass Spectrometry
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2016to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinical suspicion of OSA
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Pneumology
Zurich, Canton of Zurich, 8091
About this study
Official title: 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).
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected OSA | Persons with clinical suspicion of obstructive sleep apnoea syndrome (OSA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one hour, single measurement, no follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnoea (OSA)Studies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Malcolm Kohler, Prof. MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810158
- Sponsor's protocol ID
- BASEC-Nr.2016-00384
- Status last verified
- Oct 2018
- First submitted
- 20 Jun 2016
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34280868
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Obstructive Sleep Apnoea by Selective Secondary Electrospray Ionization - Mass Spectrometry (SESIMS)
- ClinicalTrials.gov ID
- NCT02810158
- Acronym / sponsor ID
- BASEC-Nr.2016-00384
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Study start
- Jun 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected OSA | – | –Persons with clinical suspicion of obstructive sleep apnoea syndrome (OSA) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical suspicion of OSA
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Derived from this study: PubMed 34280868Nowak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm Kohler, Prof. MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnoea (OSA) and Exhaled Breath, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSA-specific mass spectrometric pattern of VOCs in the exhaled breath (time frame: one hour, single measurement, no follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02810158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.