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

Obstructive Sleep Apnea Clinical Trial

— BrOSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04638933
• Other study ID #: BASEC-Nr. 2020-02084
• Status: Completed
• Start date: October 6, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: November 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Malcolm Kohler

Country where clinical trial is conducted

Switzerland, 

Outcome

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