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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with proven OSA (apnea-hypopnea index ≥20/h, ESS >10, age ≥18 years) and initiation of CPAP treatment

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Malcolm Kohler

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2020
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Mass spectrometry; Exhaled breath analysis
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: BASEC-Nr. 2020-02084

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No