Effect of CPAP Therapy on Molecular Breath Patterns in Patients With OSA

Effect of CPAP Therapy on Molecular Breath Patterns in Patients With OSA (BrOSA)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04638933

Acronym

BrOSA

Enrollment

Registered

2020-11-20

Start date

2020-10-06

Completion date

2023-01-31

Last updated

2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Exhaled breath analysis, Mass spectrometry

Brief 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). Furthermore, breath patterns will be assessed for correlation and association to clinical outcomes such as change in OSA severity, sleepiness, and blood pressure.

Interventions

OTHERNo intervention

No intervention

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Recently diagnosed OSA (AHI ≥20/h) * Patient is willing to start CPAP therapy * ESS \> 10 points * 18 years or above

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Exhaled breath pattern	twice during 1 month	Change in exhaled breath pattern in response to one month of CPAP treatment

Secondary

Measure	Time frame	Description
Vital signs	twice during 1 month	Correlation of breath print with changes in blood pressure and heart rate
Sleepiness	twice during 1 month	Correlation of breath print with changes in sleepiness (Epworth sleepiness scale) and Functional outcome of sleep questionnaire (FOSQ 30)
OSA severity parameter	twice during 1 month	Correlation of breath print with changes in OSA severity parameters on CPAP (e.g. AHI, ODI)
CPAP therapy	twice during 1 month	Correlation of breath print with CPAP therapy parameters (adherence and leakage)
Therapy feedback	twice during 1 month	Correlation of breath print with patients' and their partners' feedback report on CPAP machine used
Spirometry	twice during 1 month	Correlation of breath print with spirometry (FEV1, FVC)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026