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

NCT ID: NCT04638933

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-06

Study Completion Date

2023-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OSA patients

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

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Malcolm Kohler

OTHER

Sponsor Role lead

Responsible Party

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Malcolm Kohler

Prof. Dr. med.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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BASEC-Nr. 2020-02084

Identifier Type: -

Identifier Source: org_study_id