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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OSA patients<br>Patients with proven OSA (apnea-hypopnea index ≥20/h, ESS >10, age ≥18 years) and initiation of CPAP treatment | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled breath pattern | Change in exhaled breath pattern in response to one month of CPAP treatment | twice during 1 month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exhaled breath analysis, Mass spectrometry