Healthy Clinical Trial
— CARESOfficial title:
A Longitudinal Observational Study to Investigate the Patterns of Change in the Tidal Breathing CO2 Waveform, Measured Using the N-Tidal C Handset, in Patients With COPD Compared to Patients With Other Common Cardiorespiratory Conditions
NCT number | NCT04939558 |
Other study ID # | G001-21 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 2, 2021 |
Est. completion date | November 30, 2022 |
Verified date | May 2023 |
Source | TidalSense |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 744 |
Est. completion date | November 30, 2022 |
Est. primary completion date | November 2, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Modality Partnership | Birmingham | West Midlands |
Lead Sponsor | Collaborator |
---|---|
TidalSense | Innovate UK, National Institute for Health Research, United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Breath records from Healthy volunteers (no previous or current cardiorespiratory diagnoses) | 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 |
12 months from First Patient First Visit (FPFV) | |
Secondary | Breath records from participants with Asthma | 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 |
12 months from First Patient First Visit (FPFV) | |
Secondary | Breath records from participants with Congestive cardiac failure | 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 |
12 months from First Patient First Visit (FPFV) | |
Secondary | Breath records from participants with Anaemia | 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 |
12 months from First Patient First Visit (FPFV) | |
Secondary | Breath records from participants with Bronchiectasis | 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 |
12 months from First Patient First Visit (FPFV) | |
Secondary | Breath records from participants with Lung cancer | 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 |
12 months from First Patient First Visit (FPFV) | |
Secondary | Breath records from participants with Interstitial Lung Disease | 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 |
12 months from First Patient First Visit (FPFV) | |
Secondary | Breath records from participants with Long COVID | 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 |
12 months from First Patient First Visit (FPFV) | |
Secondary | Breath records from participants with Upper airway obstruction disorder | 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 |
12 months from First Patient First Visit (FPFV) |
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