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

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ClinicalTrials.gov Identifier: NCT04638933
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Malcolm Kohler, University of Zurich

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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Other: No intervention

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of CPAP Therapy on Molecular Breath Patterns in Patients With OSA (BrOSA)
Actual Study Start Date : October 6, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Exhaled breath pattern [ Time Frame: twice during 1 month ]
    Change in exhaled breath pattern in response to one month of CPAP treatment


Secondary Outcome Measures :
  1. OSA severity parameter [ Time Frame: twice during 1 month ]
    Correlation of breath print with changes in OSA severity parameters on CPAP (e.g. AHI, ODI)

  2. Vital signs [ Time Frame: twice during 1 month ]
    Correlation of breath print with changes in blood pressure and heart rate

  3. Sleepiness [ Time Frame: twice during 1 month ]
    Correlation of breath print with changes in sleepiness (Epworth sleepiness scale) and Functional outcome of sleep questionnaire (FOSQ 30)

  4. Spirometry [ Time Frame: twice during 1 month ]
    Correlation of breath print with spirometry (FEV1, FVC)

  5. CPAP therapy [ Time Frame: twice during 1 month ]
    Correlation of breath print with CPAP therapy parameters (adherence and leakage)

  6. Therapy feedback [ Time Frame: twice during 1 month ]
    Correlation of breath print with patients' and their partners' feedback report on CPAP machine used



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04638933


Contacts
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Contact: Malcolm Kohler, MD +41442553828 malcolm.kohler@usz.ch
Contact: Felix Schmidt, MSc +41442554801 felix.schmidt@usz.ch

Locations
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Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Malcolm Kohler, MD    +41442553828    malcolm.kohler@usz.ch   
Contact: Felix Schmidt, MSc    +41442554801    felix.schmidt@usz.ch   
Sponsors and Collaborators
Malcolm Kohler
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Responsible Party: Malcolm Kohler, Prof. Dr. med., University of Zurich
ClinicalTrials.gov Identifier: NCT04638933    
Other Study ID Numbers: BASEC-Nr. 2020-02084
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Malcolm Kohler, University of Zurich:
Exhaled breath analysis
Mass spectrometry
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases