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

NCT04638933 | Completed

• 1 other identifier: BASEC-Nr. 2020-02084
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Exhaled breath analysis; Mass spectrometry

Outcome Measures

Primary Outcomes (1)

• Exhaled breath pattern

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

  twice during 1 month

Secondary Outcomes (6)

• OSA severity parameter

  twice during 1 month

• Vital signs

  twice during 1 month

• Sleepiness

  twice during 1 month

• Spirometry

  twice during 1 month

• CPAP therapy

  twice during 1 month

Study Arms (1)

OSA patients

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

Other: No intervention

Interventions

No intervention OTHER

No intervention

OSA patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Recently diagnosed OSA (AHI ≥20/h)
• Patient is willing to start CPAP therapy
• ESS \> 10 points
• years or above

You may not qualify if:

• 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

Sponsors & Collaborators

• Malcolm Kohler: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 20, 2020
• Study Start: October 6, 2020
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

CH (1)