Obstructive Sleep Apnoea (OSA)NCT02050425
Breath Analysis in Obstructive Sleep Apnoea
A study testing CPAP in people with Obstructive Sleep Apnoea (OSA), run by University of Zurich at 1 site in Switzerland.
Trial summary
Clinical trial in patients with obstructive sleep apnoea that are randomised to either continue or withdraw continuous positive airway pressure therapy to identify a disease-specific exhaled breath pattern by mass spectrometry. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnoea (OSA)
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2014to Oct 2014
- Phase
- Interventional
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI) of >20/h.
- Currently >20/h oxygen desaturations (≥4% dips) during an ambulatory nocturnal pulse oximetry performed on the last night of a 4-night period without CPAP.
- Treated with CPAP for more than 12 months, minimum compliance 4h/night, apnoea-hypopnoea index (AHI) <10 with treatment (according to CPAP- download) and current ESS <10.
- Age between 20 and 75 years at trial entry.
Who cannot join
- Previous ventilatory failure (awake SpO2 <93% and PaCO2>6kPa).
- Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension or hypotension (>180/110 or <90/60mmHg)
- Previously diagnosed with Cheyne-Stokes breathing.
- Current professional driver; any previous sleep related accident.
- Acute inflammatory disease.
- Acute or chronic hepatic disease.
- Renal failure or renal replacement therapy.
- Use of inhaled drugs.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Pulmonology, University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Exhaled Breath Analysis by Mass Spectrometry in Patients With Obstructive Sleep Apnoea - a Randomised Placebo-controlled Trial.
Clinical trial in patients with obstructive sleep apnoea that are randomised to either continue or withdraw continuous positive airway pressure therapy to identify a disease-specific exhaled breath pattern by mass spectrometry.
Read the detailed description
Randomised placebo-controlled trial (therapeutic vs. subtherapeutic continuous positive airway pressure [CPAP]) including 30 OSA patients to define the effects of CPAP withdrawal (subtherapeutic CPAP) on the composition of exhaled breath analysed by mass spectrometry for identification of OSA specific markers.
- Conditions
- Obstructive Sleep Apnoea (OSA)
- Being tested
- Placebo-CPAP device, CPAP
- Keywords
- OSA, CPAP, exhaled breath
- 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.
Placebo-CPAP deviceDevice
Also called subtherapeutic CPAP
short-term CPAP withdrawal by the use of Placebo-CPAP
CPAPDevice
Patients continue therapeutic CPAP therapy
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic CPAP | Active comparator | Patients continue therapeutic continuous positive airway pressure (CPAP). Receives: Device: CPAP |
| Subtherapeutic CPAP | Placebo comparator | Placebo-CPAP device delivering subtherapeutic pressure for two weeks. Receives: Device: Placebo-CPAP device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled breath pattern.
OSA-specific mass spectrometric exhaled breath pattern.
Measured: at baseline and at follow-up (2 weeks)
Secondary outcomes (2)
apnoea-hypopnoea index (AHI)
measure of sleep apnoea severity
Measured: at baseline and at follow-up (2 weeks)
oxygen desaturation index (ODI), 4% dips
measure of sleep apnoea severity
Measured: at baseline and at follow-up (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnoea (OSA)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Principal investigator, Malcolm Kohler, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050425
- Sponsor's protocol ID
- KEK-2013-0536
- Status last verified
- Nov 2014
- First submitted
- 28 Jan 2014
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Thiel S, Haile SR, Peitzsch M, Schwarz EI, Sievi NA, Kurth S, Beuschlein F, Kohler M, Gaisl T. Endocrine responses during CPAP withdrawal in obstructive sleep apnoea: data from two randomised controlled trials. Thorax. 2019 Nov;74(11):1102-1105. doi: 10.1136/thoraxjnl-2019-213522. Epub 2019 Aug 29.
PubMed 31467191Stoberl AS, Schwarz EI, Haile SR, Turnbull CD, Rossi VA, Stradling JR, Kohler M. Night-to-night variability of obstructive sleep apnea. J Sleep Res. 2017 Dec;26(6):782-788. doi: 10.1111/jsr.12558. Epub 2017 May 26.
PubMed 28548301Schwarz EI, Martinez-Lozano Sinues P, Bregy L, Gaisl T, Garcia Gomez D, Gaugg MT, Suter Y, Stebler N, Nussbaumer-Ochsner Y, Bloch KE, Stradling JR, Zenobi R, Kohler M. Effects of CPAP therapy withdrawal on exhaled breath pattern in obstructive sleep apnoea. Thorax. 2016 Feb;71(2):110-7. doi: 10.1136/thoraxjnl-2015-207597. Epub 2015 Dec 15.
PubMed 26671307
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Breath Analysis by Mass Spectrometry in Patients With Obstructive Sleep Apnoea - a Randomised Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT02050425
- Acronym / sponsor ID
- KEK-2013-0536
- Conditions
- Obstructive Sleep Apnoea (OSA)
- Keywords
- OSA, CPAP, exhaled breath
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 30 Jan 2014 (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.
Clinical trial in patients with obstructive sleep apnoea that are randomised to either continue or withdraw continuous positive airway pressure therapy to identify a disease-specific exhaled breath pattern by mass spectrometry.
Detailed description
Randomised placebo-controlled trial (therapeutic vs. subtherapeutic continuous positive airway pressure [CPAP]) including 30 OSA patients to define the effects of CPAP withdrawal (subtherapeutic CPAP) on the composition of exhaled breath analysed by mass spectrometry for identification of OSA specific markers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic CPAP | Active comparator | Device: CPAPPatients continue therapeutic continuous positive airway pressure (CPAP). |
| Subtherapeutic CPAP | Placebo comparator | Device: Placebo-CPAP devicePlacebo-CPAP device delivering subtherapeutic pressure for two weeks. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI) of >20/h.
- Currently >20/h oxygen desaturations (≥4% dips) during an ambulatory nocturnal pulse oximetry performed on the last night of a 4-night period without CPAP.
- Treated with CPAP for more than 12 months, minimum compliance 4h/night, apnoea-hypopnoea index (AHI) <10 with treatment (according to CPAP- download) and current ESS <10.
- Age between 20 and 75 years at trial entry.
Key exclusion criteria (8 listed)
- Previous ventilatory failure (awake SpO2 <93% and PaCO2>6kPa).
- Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension or hypotension (>180/110 or <90/60mmHg)
- Previously diagnosed with Cheyne-Stokes breathing.
- Current professional driver; any previous sleep related accident.
- Acute inflammatory disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo-CPAP deviceAlso: subtherapeutic CPAPshort-term CPAP withdrawal by the use of Placebo-CPAP | Device | Subtherapeutic CPAP |
| CPAPPatients continue therapeutic CPAP therapy | Device | Therapeutic CPAP |
Primary outcome
Exhaled breath pattern.
Time frame: at baseline and at follow-up (2 weeks)
OSA-specific mass spectrometric exhaled breath pattern.
2 secondary outcomes
apnoea-hypopnoea index (AHI)
Time frame: at baseline and at follow-up (2 weeks)
oxygen desaturation index (ODI), 4% dips
Time frame: at baseline and at follow-up (2 weeks)
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 25 Nov 2014.
- Derived from this study: PubMed 31467191Thiel S, Haile SR, Peitzsch M, Schwarz EI, Sievi NA, Kurth S, Beuschlein F, Kohler M, Gaisl T. Endocrine responses during CPAP withdrawal in obstructive sleep apnoea: data from two randomised controlled trials. Thorax. 2019 Nov;74(11):1102-1105. doi: 10.1136/thoraxjnl-2019-213522. Epub 2019 Aug 29.
- Derived from this study: PubMed 28548301Stoberl AS, Schwarz EI, Haile SR, Turnbull CD, Rossi VA, Stradling JR, Kohler M. Night-to-night variability of obstructive sleep apnea. J Sleep Res. 2017 Dec;26(6):782-788. doi: 10.1111/jsr.12558. Epub 2017 May 26.
- Derived from this study: PubMed 26671307Schwarz EI, Martinez-Lozano Sinues P, Bregy L, Gaisl T, Garcia Gomez D, Gaugg MT, Suter Y, Stebler N, Nussbaumer-Ochsner Y, Bloch KE, Stradling JR, Zenobi R, Kohler M. Effects of CPAP therapy withdrawal on exhaled breath pattern in obstructive sleep apnoea. Thorax. 2016 Feb;71(2):110-7. doi: 10.1136/thoraxjnl-2015-207597. Epub 2015 Dec 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Obstructive Sleep Apnoea (OSA), 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 4 inclusion and 8 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 25 Nov 2014. 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. Some participants in this study may receive a placebo. 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?
Exhaled breath pattern. (time frame: at baseline and at follow-up (2 weeks)). 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 NCT02050425, which also lists 3 linked publications.
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 25 Nov 2014.