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Lung function test devices used are bulky and difficult to interpret in Chronic Obstructive Lung Disease. Smart Spirometer and Smart Mask are wireless devices which aim to overcome this. This study compares these results with existing Lung Function device.

Clinical Validation of Internet of Things (IoT) based Smart Spirometer and Smart Mask for COPD patients - COPD and Smart Spirometer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/01/061796
Enrollment
385
Registered
2024-01-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified

Interventions

Intervention1: NIL: NIL

Sponsors

Ministry of Electronics and Information Technology (MeitY), Government of India
Lead Sponsor
Sponsored Research and Industrial Consultancy SRIC Indian Institute of Technology Kharagpur
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Age more than 18 years. Modified Medical Research Council grade 0 to 3. Post bronchodilator Spirometry values less than or equal to 0.7. Spirometry COPD GOLD Grade 1-3.

Exclusion criteria

Exclusion criteria: Age less than 18 years Modified Medical Research Council grade 4 Spirometry GOLD Grade 4 Pregnant Women Extensive Bronchiectasis, Cystic Fibrosis) History of other Lung diseases (e.g. Pulmonary Tuberculosis, Pulmonary Fibrosis Previous Lung Surgery Active Cancer under Treatment, Suspected Lung Cancer Metal in the Chest Recent Eye Surgery Myocardial Infarction, Unstable Angina Recent Chest or Abdominal Surgery

Design outcomes

Primary

MeasureTime frame
Age, sex and comorbidities are measured. The sensitivity, specificity, positive and negative predictive value and likelihood ratio between the three devices for detection of obstruction.Timepoint: Time points will be assessed at baseline.

Secondary

MeasureTime frame
To collect data on usability evaluation of these devices by the patients, operator & investigators.Timepoint: Time points will be assessed at baseline.

Countries

India

Contacts

Public ContactKrishnarajasekhar Ottilingam Radhakrishnan

Saveetha Institute of Medical and Technical Sciences, Saveetha University

krishnarajasekhar@gmail.com919444018076

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026