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Validate Smart Breath Analyzer as Screening Tool for Diabetic, Hepatic, Renal, Lung, and Other Metabolic Disorders (RESPYR-SBA)

9. juni 2026 oppdatert av: Respyr

Early Identification of Metabolic Function Derangements Such as Diabetes, Liver, Renal Issues by Respyr Smart Breath Analyzer and Its Validation as a Screening Tool Among Diseased and Healthy Controls

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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

The smart breath analyzer, Respyr is an IoT and deep-tech enabled portable device developed by Humors Tech Pvt Ltd, Bangalore, India. The device measures volatile organic compounds (VOCs) and gases at parts-per-million and parts-per-billion levels in exhaled breath using AI and ML-based algorithms to identify metabolic derangements non-invasively.

Registration Details:

The study is registered with CTRI (CTRI/2022/09/045983) and ethics approval has been obtained from the Institutional Ethics Committee of JSS Medical College, Mysore (Ref: JSSMC/IEC/260822/07/CT Final Approval/2022-23, dated 19.12.2022). Protocol number: HTB-PROTOCOL-01, Version 1, dated 07 March 2022.

Testing Procedure:

Participants will provide an exhaled breath sample under fasting conditions, or with a minimum gap of 1 hour after consuming water and 3-4 hours after consuming food. The breath analyzer readings will be compared against standard laboratory diagnostic values including FBS/RBS, RFT, LFT, spirometry, and lipid profile, all tested within 15 days of participation.

Regulatory Compliance:

The study follows ICH-GCP guidelines, CDSCO-DCGI and New Drugs and Clinical Trial Rules 2019, and ICMR Ethical Guidelines for Biomedical Research on Human Participants.

Studietype

Observasjonsmessig

Registrering (Faktiske)

3000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • India
    • Karnataka
      • Mysore, Karnataka, India, 570015
        • Dept. of Community Medicine, JSS Medical College

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Healthy volunteers and patients with confirmed metabolic disorders including type 2 diabetes, liver disease, kidney disease, and lung disease recruited from JSS Hospital and Medical College, Mysore, India.

Beskrivelse

Inclusion Criteria:

  • Participant must either be a completely healthy individual as confirmed by blood examination, or a known case of diabetes, kidney disease, liver disease, and lung disease with relevant diagnostic reports tested within 15 days of participation
  • All genders and ethnicities
  • Age 18 to 75 years
  • Participant who has given informed consent
  • Participant must be fully vaccinated for COVID-19
  • Participant must use the smart breath analyzer at fasting condition; if not fasting, minimum gap of 1 hour after water and 3-4 hours after food

Exclusion Criteria:

  • Individual less than 18 or above 75 years of age
  • Pregnant and lactating females
  • Known case of ongoing illness such as Cancer, AIDS, COVID-19, Cough, Fever, TB, Chickenpox, Influenza, Mumps, or Tonsillitis
  • Individual who has not given informed consent

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Healthy Volunteers
Apparently healthy individuals aged 18-75 years with normal levels of fasting and postprandial blood sugar, renal function test, liver function test, and lung function test, as confirmed by blood examination conducted within 15 days of participation. Participants will undergo exhaled breath analysis using the Respyr smart breath analyzer device.
Patients with Metabolic Disorders
Patients aged 18-75 years with confirmed diagnosis of one or more metabolic disorders including type 2 diabetes (confirmed by FBS/RBS), kidney disease (confirmed by RFT), liver disease (confirmed by LFT), and lung disease (confirmed by spirometry), with relevant diagnostic reports tested within 15 days of participation. Participants will undergo exhaled breath analysis using the Respyr smart breath analyzer device.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Validation of Smart Breath Analyzer for Screening of Metabolic Disorders
Tidsramme: Baseline
Development and validation of an IoT and deep-tech enabled smart breath analyzer for accurate and early screening of metabolic derangements including diabetes, kidney disease, liver disease, lung disease, AI and ML-based algorithms will be generated to provide an affordable, non-invasive screening option enabling timely preventive healthcare action
Baseline

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Triglycerides
Tidsramme: baseline
Measured in mg/dl. Normal range: <150 mg/dl. Compared with smart breath analyzer readings.
baseline
HDL
Tidsramme: baseline
Measured in mg/dl. Normal range: 40-60 mg/dl. Compared with smart breath analyzer readings.
baseline
VLDL
Tidsramme: Baseline
Measured in mg/dl. Normal range: 2-30 mg/dl. Compared with smart breath analyzer readings.
Baseline
LDL
Tidsramme: Baseline
Measured in mg/dl. Normal range: 100-129 mg/dl. Compared with smart breath analyzer readings.
Baseline
Cholesterol/ HDL Ratio
Tidsramme: Baseline
Ratio with no unit. Normal range: <4.5. Compared with smart breath analyzer readings.
Baseline
LDL/HDL Ratio
Tidsramme: Baseline
Ratio with no unit. Normal range: <3. Compared with smart breath analyzer readings.
Baseline
Serum Protein Level (Total Protein, Albumin, Globulin) assessed by Liver Function Test (LFT)
Tidsramme: Baseline
Measured in g/dl. Normal ranges: Total Protein 6.4-8.3 g/dl, Albumin 3.4-4.8 g/dl, Globulin 2-3.5 g/dl. Compared with smart breath analyzer readings.
Baseline
Serum Creatinine Level assessed by Renal Function Test (RFT)
Tidsramme: Baseline
Measured in mg/dl. Normal range: 0.7-1.3 mg/dl. Compared with smart breath analyzer readings.
Baseline
Fasting Blood Glucose Level assessed by Fasting Blood Sugar Test (FBS)
Tidsramme: Baseline
Measured in mg/dl. Normal range: 75-110 mg/dl. Compared with smart breath analyzer readings.
Baseline
HBA1C (4.0-5.6)
Tidsramme: Baseline
HbA1c Level assessed by Glycated Hemoglobin Test
Baseline
Post Prandial (<140)
Tidsramme: Baseline
Postprandial Blood Glucose Level assessed by Post Prandial Blood Sugar Test (PPBS)
Baseline
Total/Direct/Indirect Bilirubin
Tidsramme: Baseline
Serum Bilirubin Level (Total, Direct, Indirect) assessed by Liver Function Test (LFT)
Baseline
SGOT/AST (<37 U/L)
Tidsramme: Baseline
SGOT/AST Level assessed by Liver Function Test (LFT
Baseline
ALP (30-90 U/L)
Tidsramme: Baseline
Alkaline Phosphatase (ALP) Level assessed by Liver Function Test (LFT)
Baseline
Total Protein, Albumin, Globulin, A/G ratio
Tidsramme: Baseline
Serum Protein Level (Total Protein, Albumin, Globulin, A/G Ratio) assessed by Liver Function Test (LFT)
Baseline
Serum urea (13-43 mg/dl)
Tidsramme: Baseline
Serum Urea Level assessed by Renal Function Test (RFT)
Baseline
Uric acid (3.5-7.2 mg/dl)
Tidsramme: Baseline
Serum Uric Acid Level assessed by Renal Function Test (RFT)
Baseline
Calcium, Phosphorus
Tidsramme: Baseline
Serum Calcium and Phosphorus Level assessed by Renal Function Test (RFT)
Baseline
Sodium, Potassium, Chloride
Tidsramme: Baseline
Serum Electrolytes (Sodium, Potassium, Chloride) assessed by Renal Function Test (RFT)
Baseline

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Respyr

Samarbeidspartnere

JSS Medical College Hospital

Etterforskere

  • Hovedetterforsker: Nayanabai Shabadi, M.D, JSS Medical College, Mysore

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. oktober 2022

Primær fullføring (Faktiske)

3. oktober 2023

Studiet fullført (Faktiske)

5. oktober 2023

Datoer for studieregistrering

Først innsendt

1. juni 2026

Først innsendt som oppfylte QC-kriteriene

9. juni 2026

Først lagt ut (Faktiske)

12. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HUMORS-CTRI-2022-045983
  • CTRI/2022/09/045983 (Registeridentifikator: Clinical Trials Registry India)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data contains proprietary device output from a commercially sensitive medical technology. Data sharing is restricted due to intellectual property considerations and patient confidentiality

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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