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

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Other: No intervention

• Registration Number: NCT04638933
• Lead Sponsor: Malcolm Kohler

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-06
• Study First Submitted: 2020-11-16
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-20
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OSA patients	No intervention	Patients with proven OSA (apnea-hypopnea index ≥20/h, ESS \>10, age ≥18 years) and initiation of CPAP treatment

Primary Outcome Measures

Name	Time	Method
Exhaled breath pattern	twice during 1 month	Change in exhaled breath pattern in response to one month of CPAP treatment

Secondary Outcome Measures

Name	Time	Method
Spirometry	twice during 1 month	Correlation of breath print with spirometry (FEV1, FVC)
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
Vital signs	twice during 1 month	Correlation of breath print with changes in blood pressure and heart rate
OSA severity parameter	twice during 1 month	Correlation of breath print with changes in OSA severity parameters on CPAP (e.g. AHI, ODI)
Sleepiness	twice during 1 month	Correlation of breath print with changes in sleepiness (Epworth sleepiness scale) and Functional outcome of sleep questionnaire (FOSQ 30)

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland