Obstructive Sleep ApneaBrOSANCT04638933
Effect of CPAP Therapy on Molecular Breath Patterns in Patients With OSA
An observational study of Obstructive Sleep Apnea, run by Malcolm Kohler at 1 site in Switzerland.
Trial summary
Determination of changes in molecular breath patterns in OSA patients, naïve for OSA treatment before and after one month of CPAP therapy by untargeted, secondary electrospray ionisation-high resolution mass spectrometry (SESI-HRMS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 53 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Oct 2020to 31 Jan 2023
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients with proven OSA (apnea-hypopnea index ≥20/h, ESS >10, age ≥18 years) and initiation of CPAP treatment
Who may be able to join
- Recently diagnosed OSA (AHI ≥20/h)
- Patient is willing to start CPAP therapy
- ESS > 10 points
- 18 years or above
Who cannot join
- Moribund or severe disease prohibiting protocol adherence
- Use of oxygen therapy or home ventilation
- Physical or intellectual impairment precluding informed consent or protocol adherence
- Known malignancy, acute pulmonary disease, drug or alcohol abuse, known active inflammatory diseases (e.g. autoimmune disease), relevant congenital defects e.g. amino acid metabolism defect, relevant endocrinological disease, renal failure (GFR < 15 mL/min)
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of CPAP Therapy on Molecular Breath Patterns in Patients With OSA (BrOSA)
Determination of changes in molecular breath patterns in OSA patients, naïve for OSA treatment before and after one month of CPAP therapy by untargeted, secondary electrospray ionisation-high resolution mass spectrometry (SESI-HRMS). Furthermore, breath patterns will be assessed for correlation and association to clinical outcomes such as change in OSA severity, sleepiness, and blood pressure.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- No intervention
- Keywords
- Exhaled breath analysis, Mass spectrometry
- 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.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| OSA patients | Patients with proven OSA (apnea-hypopnea index ≥20/h, ESS >10, age ≥18 years) and initiation of CPAP treatment Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled breath pattern
Change in exhaled breath pattern in response to one month of CPAP treatment
Measured: twice during 1 month
Secondary outcomes (6)
OSA severity parameter
Correlation of breath print with changes in OSA severity parameters on CPAP (e.g. AHI, ODI)
Measured: twice during 1 month
Vital signs
Correlation of breath print with changes in blood pressure and heart rate
Measured: twice during 1 month
Sleepiness
Correlation of breath print with changes in sleepiness (Epworth sleepiness scale) and Functional outcome of sleep questionnaire (FOSQ 30)
Measured: twice during 1 month
Spirometry
Correlation of breath print with spirometry (FEV1, FVC)
Measured: twice during 1 month
CPAP therapy
Correlation of breath print with CPAP therapy parameters (adherence and leakage)
Measured: twice during 1 month
Therapy feedback
Correlation of breath print with patients' and their partners' feedback report on CPAP machine used
Measured: twice during 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start6 Oct 2020
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malcolm Kohler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Malcolm Kohler, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638933
- Sponsor's protocol ID
- BASEC-Nr. 2020-02084
- Acronym
- BrOSA
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2020
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CPAP Therapy on Molecular Breath Patterns in Patients With OSA (BrOSA)
- ClinicalTrials.gov ID
- NCT04638933
- Acronym / sponsor ID
- BrOSA / BASEC-Nr. 2020-02084
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Exhaled breath analysis, Mass spectrometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Malcolm KohlerUniversity, hospital or other
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 20 Nov 2020 (actual)
- 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.
Determination of changes in molecular breath patterns in OSA patients, naïve for OSA treatment before and after one month of CPAP therapy by untargeted, secondary electrospray ionisation-high resolution mass spectrometry (SESI-HRMS). Furthermore, breath patterns will be assessed for correlation and association to clinical outcomes such as change in OSA severity, sleepiness, and blood pressure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSA patients | – | Other: No interventionPatients with proven OSA (apnea-hypopnea index ≥20/h, ESS >10, age ≥18 years) and initiation of CPAP treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with proven OSA (apnea-hypopnea index ≥20/h, ESS >10, age ≥18 years) and initiation of CPAP treatment
Key inclusion criteria (4 listed)
- Recently diagnosed OSA (AHI ≥20/h)
- Patient is willing to start CPAP therapy
- ESS > 10 points
- 18 years or above
Key exclusion criteria (5 listed)
- Moribund or severe disease prohibiting protocol adherence
- Use of oxygen therapy or home ventilation
- Physical or intellectual impairment precluding informed consent or protocol adherence
- Known malignancy, acute pulmonary disease, drug or alcohol abuse, known active inflammatory diseases (e.g. autoimmune disease), relevant congenital defects e.g. amino acid metabolism defect, relevant endocrinological disease, renal failure (GFR < 15 mL/min)
- Pregnant patients
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 |
|---|---|---|
| No interventionNo intervention | Other | OSA patients |
Primary outcome
Exhaled breath pattern
Time frame: twice during 1 month
Change in exhaled breath pattern in response to one month of CPAP treatment
6 secondary outcomes
OSA severity parameter
Time frame: twice during 1 month
Vital signs
Time frame: twice during 1 month
Sleepiness
Time frame: twice during 1 month
Spirometry
Time frame: twice during 1 month
CPAP therapy
Time frame: twice during 1 month
Therapy feedback
Time frame: twice during 1 month
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 29 Nov 2023.
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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?
An observational study of Obstructive Sleep Apnea, run by Malcolm Kohler 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 5 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 29 Nov 2023. 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?
Exhaled breath pattern (time frame: twice during 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2023.