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

9 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

3000

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Validation of Smart Breath Analyzer for Screening of Metabolic Disorders
Délai: 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

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Respyr

Collaborateurs

JSS Medical College Hospital

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

3 octobre 2022

Achèvement primaire (Réel)

3 octobre 2023

Achèvement de l'étude (Réel)

5 octobre 2023

Dates d'inscription aux études

Première soumission

1 juin 2026

Première soumission répondant aux critères de contrôle qualité

9 juin 2026

Première publication (Réel)

12 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HUMORS-CTRI-2022-045983
  • CTRI/2022/09/045983 (Identificateur de registre: Clinical Trials Registry India)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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