Optimization of Exhaled Biomarker Collection and Analysis

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT05322785
Status
Enrolling By Invitation

Conditions

  • Healthy
  • Respiratory Disease

Eligibility Criteria

Sex
ALL
Age
4 Years - 110 Years
Healthy Volunteers
Accepted

Interventions

  • Breath collection — OTHER
    Exhaled breath will be passively collected from subjects during quiet oral breathing through a simple mouthpiece or mask

Study Details

This is an exploratory study designed to optimize, standardize, and validate novel breath biomarkers; there are no objective endpoints. The goal of this study is to generate pilot data to be used to generate hypothesis-driven studies.

Key Dates

Start date
Feb 2, 2020
Status verified
Mar 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Other: Single Visit breath collection
    Following informed consent, exhaled breath will be passively collected from subjects during quiet oral breathing through a simple mouthpiece or mask. Exhaled breath will be diverted into a collection device, which may include a bag, tube, or other device with minimal resistance. The collection process, including completing forms, will not exceed 30 minutes. At no time will the patients be breathing anything other than ambient air with or without oxygen enrichment as clinically indicated. Inhaled air will not be manipulated.

Primary Outcome Measure

Breath amount, pH, components [ Time Frame: During the exhaled breath collection procedure, not to exceed 30 minutes ]

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University School of Medicine - Wells Center for Pediatric ResearchIndianapolisIndiana46202-

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Indiana University School of Medicine - Wells Center for Pediatric Research· Indianapolis, IN

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