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OpenTrials
Completed

NCT Number: NCT04638933

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich

Zurich, 8091, Switzerland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Exhaled breath pattern

    Time frame: twice during 1 month

    Change in exhaled breath pattern in response to one month of CPAP treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Malcolm Kohler

Other

Registry information

Official study title

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

Acronym: BrOSA

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 20, 2020
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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