Cardiorespiratory Diagnostic Study

Completed

• Conditions: Asthma; Long COVID; COPD; Lung Cancer; Bronchiectasis; Interstitial Lung Disease; Healthy; Congestive Cardiac Failure; Upper Respiratory Disease; Anemia
• Interventions: Device: N-Tidal C handset

• Registration Number: NCT04939558
• Lead Sponsor: TidalSense

Brief Summary

This study uses a new breathing device called 'N-Tidal C' handset which measures breathing patterns. Investigators have found that people with cardiac and respiratory illnesses breathe out a gas, called carbon dioxide (CO2), in a different way to healthy people. The pattern of breathed out CO2 (the waveform) varies according to the underlying health of the user's lungs. Monitoring these changes may help doctors to more accurately diagnose and monitor the most common and serious respiratory conditions.

Detailed Description

Chronic Obstructive Pulmonary Disease (COPD) is among the most prevalent respiratory conditions, and in the top five causes of death worldwide. However, mis-diagnosis rates are high (both under- and over- diagnosis), owing to the lack of a simple, reliable and specific diagnostic test. In addition, COPD is often diagnosed late in the natural history of the disease, which misses the opportunity for early intervention, with early treatment and health-behaviour changes (smoking cessation).

Spirometry, the current gold standard for diagnosis, is unreliable (technique-dependent), crude (measures airflow), and non-specific (multiple respiratory conditions can produce similar patterns on spirometry). It also relies on proper administration by specially trained members of staff. As a result, spirometry is often (a) not performed before a speculative diagnosis of COPD is made, and (b) performed poorly, resulting in poor-quality information on which to base a respiratory diagnosis.

There is therefore a need for a simple, reliable, robust and accurate test for diagnosing COPD which is non-operator dependent, and non-technique dependent.

Currently, capnography is invasive, expensive and can only be recorded in specialist centres via a nasal cannula and micro-stream sampling of expired carbon dioxide in the intensive care setting. The N-Tidal C (NTC) handset, a new (CE-marked), hand-held, wireless device has been developed to monitor the user's Tidal Breathing CO2 (TBCO2) waveforms at rest, during normal tidal breathing. This device can be safely operated in the home environment, has a battery life of weeks, and has an isolated, disposable, breath pathway that isolates an individual's breath from the rest of the device, making it safe to reuse between patients after the outer casing has been decontaminated using a 3-stage disinfection process.

The N-Tidal technology has the potential to offer new insights into lung physiology (above and beyond those currently available from spirometry and lung function testing), and early evidence from TidalSense's previous clinical studies suggests that the TBCO2 data could be used to fingerprint and diagnose COPD.

Study Timeline

• Study Start: 2021-06-02
• Study First Submitted: 2021-06-03
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-25
• Primary Completion: 2022-11-02
• Study Completion: 2022-11-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-31
• Last Update Posted: 2023-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 744

Inclusion Criteria

• Age > 18 years
• Healthy volunteer (with no previous or current chronic cardiorespiratory diagnoses)

One of the following cardiorespiratory diagnoses:

• COPD (GOLD 1, 2, 3 / A, B, C)*
• Asthma (mild to moderate, not labelled as severe)*
• Congestive cardiac failure*
• Anaemia (with at least 50% of participants recruited having no history of chronic cardiorespiratory conditions)*
• Bronchiectasis (acquired or genetic, e.g. cystic fibrosis or other primary ciliary dyskinesias)*
• Lung cancer (including rare types e.g. mesothelioma)*
• Interstitial Lung Disease (including pulmonary fibrosis pneumoconiosis, asbestosis, sarcoidosis, amyloidosis)*
• Long COVID*
• Upper airway obstruction disorder*
• [Active pulmonary hypertension]
• [Extrinsic Allergic Alveolitis]
• [Active pulmonary embolism]

Exclusion Criteria

• Participants who, in the opinion of the chief investigator, or their delegate, are unlikely to comply with the requirements of the study;
• Diagnosis of neuromuscular disorders;
• Concurrent diagnosis of cardiorespiratory conditions (other than those listed in the inclusion criteria above) that, in the opinion of the chief investigator, would impact the conduct of the study
• Participants who are acutely unwell, e.g. active exacerbation, very short of breath e.g. severe COPD (GOLD 4 / D) or end-stage IPF.
• Inability to give written informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anaemia	N-Tidal C handset	55 participants - with at least 50% of participants recruited having no history of chronic cardiorespiratory conditions
Long COVID	N-Tidal C handset	55 participants
Chronic Obstructive Pulmonary Disease	N-Tidal C handset	245 participants - GOLD 1, 2, 3 / A, B, C
Congestive cardiac failure	N-Tidal C handset	55 participants
Upper airway obstruction disorder	N-Tidal C handset	55 participants
Healthy	N-Tidal C handset	55 participants - with no previous or current chronic cardiorespiratory diagnoses
Asthma	N-Tidal C handset	55 participants - Mild to moderate, not labelled as severe.
Lung cancer	N-Tidal C handset	55 participants - including rare types e.g. mesothelioma
Interstitial Lung Disease	N-Tidal C handset	55 participants - including pulmonary fibrosis pneumoconiosis, asbestosis, sarcoidosis, amyloidosis
Bronchiectasis	N-Tidal C handset	55 participants - Acquired or genetic, e.g. cystic fibrosis or other primary ciliary dyskinesias

Primary Outcome Measures

Name	Time	Method
Breath records from participants with Chronic Obstructive Pulmonary Disease (COPD)	12 months from First Patient First Visit (FPFV)	Tidal Breathing CO2 waveform data from 245 participants collected using the N-Tidal C Handset.; Each participant delivering 2 x breath records per day for 14 days = 6860 records

Secondary Outcome Measures

Name	Time	Method
Breath records from participants with Lung cancer	12 months from First Patient First Visit (FPFV)	Tidal Breathing CO2 waveform data from 55 participants collected using the N-Tidal C Handset.; Each participant delivering 2 x breath records per day for 14 days = 1540 records
Breath records from Healthy volunteers (no previous or current cardiorespiratory diagnoses)	12 months from First Patient First Visit (FPFV)	Tidal Breathing CO2 waveform data from 55 participants collected using the N-Tidal C Handset.; Each participant delivering 2 x breath records per day for 14 days = 1540 records
Breath records from participants with Asthma	12 months from First Patient First Visit (FPFV)	Tidal Breathing CO2 waveform data from 55 participants collected using the N-Tidal C Handset.; Each participant delivering 2 x breath records per day for 14 days = 1540 records
Breath records from participants with Interstitial Lung Disease	12 months from First Patient First Visit (FPFV)	Tidal Breathing CO2 waveform data from 55 participants collected using the N-Tidal C Handset.; Each participant delivering 2 x breath records per day for 14 days = 1540 records
Breath records from participants with Upper airway obstruction disorder	12 months from First Patient First Visit (FPFV)	Tidal Breathing CO2 waveform data from 55 participants collected using the N-Tidal C Handset.; Each participant delivering 2 x breath records per day for 14 days = 1540 records
Breath records from participants with Congestive cardiac failure	12 months from First Patient First Visit (FPFV)	Tidal Breathing CO2 waveform data from 55 participants collected using the N-Tidal C Handset.; Each participant delivering 2 x breath records per day for 14 days = 1540 records
Breath records from participants with Anaemia	12 months from First Patient First Visit (FPFV)	Tidal Breathing CO2 waveform data from 55 participants collected using the N-Tidal C Handset.; Each participant delivering 2 x breath records per day for 14 days = 1540 records
Breath records from participants with Bronchiectasis	12 months from First Patient First Visit (FPFV)	Tidal Breathing CO2 waveform data from 55 participants collected using the N-Tidal C Handset.; Each participant delivering 2 x breath records per day for 14 days = 1540 records
Breath records from participants with Long COVID	12 months from First Patient First Visit (FPFV)	Tidal Breathing CO2 waveform data from 55 participants collected using the N-Tidal C Handset.; Each participant delivering 2 x breath records per day for 14 days = 1540 records

Trial Locations

Locations (1)

Modality Partnership; 🇬🇧 Birmingham, West Midlands, United Kingdom