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Validate Smart Breath Analyzer as Screening Tool for Diabetic, Hepatic, Renal, Lung, and Other Metabolic Disorders

NCT07646015 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2026-06-12

No results posted yet for this study

Summary

This is a prospective, multicentric, non-treatment study to build and validate a portable, non-invasive smart breath analyzer that can screen underlying health issues using exhaled breath. The study will be conducted with healthy participants and participants with known cases of diabetes, kidney related issues, liver related issues, and lung related issues as confirmed by pathology reports. In phase 1, 500 apparently healthy individuals with normal levels of fasting and postprandial blood sugar, renal function test, liver function test, and lung function test will be recruited. In phase 2, 500 patients of type 2 diabetes, liver function, renal function, and lung function derangements each diagnosed by 10% increment above normal values will be enrolled. In phase 3, validation of the breath analyzer as a screening tool for early identification of type 2 diabetes, liver, renal, lung and other metabolic function derangements will be done by randomly assigning healthy and diseased participants for exhaled breath sample analysis. The study is based on the principle of exhaled breath analysis where parts per million and parts per billion level of volatile organic compounds and gases in human breath will be measured. AI based algorithms will be generated to effectively screen unhealthy biomarker levels, enabling timely preventive action.

Conditions

Sponsors & Collaborators

  • JSS Medical College Hospital

    collaborator UNKNOWN

  • Respyr

    lead INDUSTRY

Principal Investigators

  • Nayanabai Shabadi, M.D · JSS Medical College, Mysore

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-03
Primary Completion
2023-10-03
Completion
2023-10-05

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07646015 on ClinicalTrials.gov