Exhaled Breath Analysis in Human Subjects

Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS) in Human Subjects

Identification of exhaled breath pattern of human subjects

Study Overview

• Status: Recruiting
• Conditions: Exhaled Breath Pattern After Medication Intake, in OSA Patients, or Other Pulmonary Diseases
• Intervention / Treatment: Other: No intervention

Detailed Description

Breath analysis with mass spectormetry as a non-invasive method to identfy exhaled breath patterns.

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Malcolm Kohler, MD; Phone Number: +41442551111; Email: malcolm.kohler@usz.ch
• Study Contact Backup: Name: Noriane Sievi, MSc; Phone Number: +41442559815; Email: noriane.sievi@usz.ch

Study Locations

• Switzerland
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8091
      • Recruiting
      • University Hospital Zurich
      • Contact: Malcolm Kohler, MD; Email: malcolm.kohler@usz.ch
      • Contact: Noriane Sievi, MSc; Phone Number: +41442559815; Email: noriane.sievi@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Population of human subjects with heart failure, dementia syndrome, parkinson disease, obstructive sleep apnea, chronic obstructive pulmonary disease, pneumonia, specific medication use.

Description

Inclusion Criteria:

• >= 18 years
• Informed consent

Exclusion Criteria:

• specific exclusion criteria for different subgroups

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exhaled breath pattern	mass spectrometric profile of exhaled breath pattern of human subjects	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chemical structure of exhaled breath molecules	The identification of the chemical structure of exhaled breath molecules	baseline
Body fluids	The correlations of identified molecules in exhaled breath with body fluids	baseline
Disease marker	The correlation of a distinct disease marker with a breath print or breath feature	baseline
Distinguish between disease	The use of a breath print to distinguish between disease and/or health state	baseline
Health state	The correlation of breath prints to subjective health state and/or quality of life	baseline
Medication	Response to medication and toxicity as a function of blood/breath drug concentrations	baseline
Excretion of drugs	Correlation between lung function and the excretion of drugs in exhaled breath	baseline

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Deep Breath Intelligence (DBI)

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2019
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: 2019-00030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: if requested

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No