Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04567498

eNose-TB: Electronic Nose for Tuberculosis Screening

An electronic-nose (e-nose) is being investigated as a diagnostic tool for tuberculosis by examining exhaled breath of the patients. Universitas Gadjah Mada has developed an e-nose device for TB diagnostic tool. Here the investigators test the device in order to analyze the sensitivity and specificity electronic-nose as a screening tool for tuberculosis particularly in remote area. Various factors (gender, age, race, and location) are considered in the algorithm training to develop an inclusive eNose. Access barriers, especially those faced by women, are also assessed.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Behavior Coitus Gram-Positive Bacterial Infections Infections Mycobacterium Infections Sexual Behavior

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Balai Kesehatan Masyarakat Klaten, Klaten, Central Java, Indonesia

Loading trial locations.

About this study

The study population consists of 2 groups:

Group 1 - presumptive TB patients. Group 2 - residents of area with high risk of TB.

Study participants provide written informed consent. The participants are asked to breathe normally using a mask for 2 times then inhale and exhale in a forced expiratory volume to the air collecting bag until the collecting bag is full (two times). The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter protecting the e-nose from microbes. The breath pattern will be recorded in the e-nose device, which is connected to a laptop that will display the recorded breath pattern. Other data are collected: clinical symptoms, results of chest X-ray, smear microscopic, and Xpert MTB/Rif examinations.

Demographic (gender, age, race, and location) and clinical data (symptoms, physical examination, laboratory examinations) are collected. Access barriers, especially for women, are also assessed through questionnaire and interviews.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:

Validation Phase (Group 1):

  • Adult and children
  • Suspected of having TB
  • Agree to participate in the study
  • Able to produce exhaled air samples
  • Able to produce samples for Xpert MTB/Rif examination

Screening Phase (Group 2):

  • Adult and children
  • Agree to participate in the study
  • Able to produce exhaled air samples
  • Currently not in TB treatment
  • Exclusion Criteria
  • Invalid measurements of breath tests
  • Incomplete CXR data
  • Missing specimens
  • Unable to breath normally for 2 minutes due to respiratory illness

Treatment and study plan

exhaled breath sampling

Other

The participants are requested to quietly sit and breathe to the air collecting bag until the collecting bag is full. The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter. The data are read and stored in the e-nose machine.

Primary outcomes

  1. Diagnostic accuracy of electronic nose signal in screening tuberculosis that is measured through sensitivity, specificity, PPV, NPV

    Time frame: 2 years

    sensitivity, specificity, positive predictive value, negative predictive value of e-nose signal in diagnosing TB, factors influencing the diagnostic accuracy

  2. Access barriers, measured through questionnaire, interview, and focus group discussion

    Time frame: 2 years

    access barriers to the TB screening that are measured through questionnaire, interview, and focus group discussion

Secondary outcomes

  1. Time of a screening algorithm with eNose-TB, measured in days

    Time frame: 2 years

    Time of a screening algorithm with eNose-TB to obtain additional detection of one TB case, measured in days

Sponsors and collaborators

Lead sponsor

Gadjah Mada University

Other

Registry information

Official study title

eNose-TB: Electronic Nose for Tuberculosis Screening in Indonesia

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Sep 28, 2020
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.