Cardiorespiratory Diagnostic Study

NCT04939558 | Completed

• 1 other identifier: G001-21
• Study Type: observational
• Target: 744
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Asthma; Lung Cancer; Anemia; Congestive Cardiac Failure; Bronchiectasis; Interstitial Lung Disease; Long COVID; Upper Respiratory Disease; Healthy

Outcome Measures

Primary Outcomes (1)

• Breath records from participants with Chronic Obstructive Pulmonary Disease (COPD)

  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

  12 months from First Patient First Visit (FPFV)

Secondary Outcomes (9)

• Breath records from Healthy volunteers (no previous or current cardiorespiratory diagnoses)

  12 months from First Patient First Visit (FPFV)

• Breath records from participants with Asthma

  12 months from First Patient First Visit (FPFV)

• Breath records from participants with Congestive cardiac failure

  12 months from First Patient First Visit (FPFV)

• Breath records from participants with Anaemia

  12 months from First Patient First Visit (FPFV)

• Breath records from participants with Bronchiectasis

  12 months from First Patient First Visit (FPFV)

Study Arms (10)

Chronic Obstructive Pulmonary Disease

245 participants - GOLD 1, 2, 3 / A, B, C

Device: N-Tidal C handset

Asthma

55 participants - Mild to moderate, not labelled as severe.

Device: N-Tidal C handset

Congestive cardiac failure

55 participants

Device: N-Tidal C handset

Anaemia

55 participants - with at least 50% of participants recruited having no history of chronic cardiorespiratory conditions

Device: N-Tidal C handset

Bronchiectasis

55 participants - Acquired or genetic, e.g. cystic fibrosis or other primary ciliary dyskinesias

Device: N-Tidal C handset

Lung cancer

55 participants - including rare types e.g. mesothelioma

Device: N-Tidal C handset

Interstitial Lung Disease

55 participants - including pulmonary fibrosis pneumoconiosis, asbestosis, sarcoidosis, amyloidosis

Device: N-Tidal C handset

Long COVID

55 participants

Device: N-Tidal C handset

Upper airway obstruction disorder

55 participants

Device: N-Tidal C handset

Healthy

55 participants - with no previous or current chronic cardiorespiratory diagnoses

Device: N-Tidal C handset

Interventions

N-Tidal C handset DEVICE

Participants are to use the 'N-Tidal C' handset every day for 14 days. This will ideally be two times a day (once in the morning and once in the evening, before using any regular inhalers). Each breath record requires the participant to breathe through the mouthpiece for 75 seconds in a relaxed manner.

Anaemia; Asthma; Bronchiectasis; Chronic Obstructive Pulmonary Disease; Congestive cardiac failure; Healthy; Interstitial Lung Disease; Long COVID; Lung cancer; Upper airway obstruction disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from among the primary care patient population served by the Modality (GP) partnership. Participants will either be healthy (no underlying cardiorespiratory diagnoses) or have one of the following conditions: COPD, asthma, congestive cardiac failure (heart failure), bronchiectasis (including cystic fibrosis), anaemia, lung cancer (including mesothelioma), pulmonary fibrosis, long COVID, an upper airway obstruction disorder, pulmonary embolism, pulmonary hypertension, extrinsic allergic alveolitis. Participants will deliberately be recruited from a wide range of demographic backgrounds, to provide diversity of: age, gender, geographic location and ethnicity.

You may qualify if:

• 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\*
• \[Active pulmonary hypertension\]
• \[Extrinsic Allergic Alveolitis\]
• \[Active pulmonary embolism\]

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• TidalSense: lead
• Innovate UK: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Modality Partnership

Birmingham, West Midlands, B19 1BP, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Lung Neoplasms; Anemia; Heart Failure; Bronchiectasis; Lung Diseases, Interstitial; Post-Acute COVID-19 Syndrome; Respiration Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Heart Diseases; Cardiovascular Diseases; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Post-Infectious Disorders

Study Officials

• Zishan Ali, MBBS BSc

  Modality Partnership

  PRINCIPAL INVESTIGATOR

• Elango Vijaykumar, MBBS, FRCG

  Modality Partnership

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 25, 2021
• Study Start: June 2, 2021
• Primary Completion: November 2, 2022
• Study Completion: November 30, 2022
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

GB (1)