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

2026年6月9日更新者：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.

調査の概要

状態

完了

条件

詳細な説明

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.

研究の種類

観察的

入学 (実際)

3000

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

インド
- Karnataka
  - Mysore、Karnataka、インド、570015
    - Dept. of Community Medicine, JSS Medical College

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

大人
高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

グループ/コホートの数

コホートと介入

グループ/コホート
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.

グループ/コホート

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.

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Validation of Smart Breath Analyzer for Screening of Metabolic Disorders 時間枠：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

二次結果の測定

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Respyr

協力者

JSS Medical College Hospital

捜査官

主任研究者：Nayanabai Shabadi, M.D、JSS Medical College, Mysore

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

A multicentric observational study in India to validate Humors' Smart Breath Analyzer for non-invasive screening of diabetes, liver, kidney, and lung using ML based exhaled breath analysis.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2022年10月3日

一次修了 (実際)

2023年10月3日

研究の完了 (実際)

2023年10月5日

試験登録日

最初に提出

2026年6月1日

QC基準を満たした最初の提出物

2026年6月9日

最初の投稿 (実際)

2026年6月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月12日

QC基準を満たした最後の更新が送信されました

2026年6月9日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

HUMORS-CTRI-2022-045983
CTRI/2022/09/045983 (レジストリ識別子：Clinical Trials Registry India)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。