COPDCARESNCT04939558
Cardiorespiratory Diagnostic Study
An observational study of COPD and Asthma, run by TidalSense at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD, Asthma, Lung Cancer
- What is being tested?
- N-Tidal C handset
- Type of treatment
- Medical device
- How many people
- 744 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jun 2021to 30 Nov 2022
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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*
Show all 15Show fewer
- 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]
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Modality Partnership
Birmingham, West Midlands, B19 1BP
About this study
Official 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
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.
Read the 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.
- Conditions
- COPD, Asthma, Lung Cancer, Anemia, Congestive Cardiac Failure, Bronchiectasis
- Being tested
- N-Tidal C handset
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Lung Neoplasms, Anemia, Heart Failure, Bronchiectasis, Lung Diseases, Interstitial, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Tidal C handsetDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | 245 participants - GOLD 1, 2, 3 / A, B, C Receives: Device: N-Tidal C handset | |
| Asthma | 55 participants - Mild to moderate, not labelled as severe. Receives: Device: N-Tidal C handset | |
| Congestive cardiac failure | 55 participants Receives: Device: N-Tidal C handset | |
| Anaemia | 55 participants - with at least 50% of participants recruited having no history of chronic cardiorespiratory conditions Receives: Device: N-Tidal C handset | |
| Bronchiectasis | 55 participants - Acquired or genetic, e.g. cystic fibrosis or other primary ciliary dyskinesias Receives: Device: N-Tidal C handset | |
| Lung cancer | 55 participants - including rare types e.g. mesothelioma Receives: Device: N-Tidal C handset | |
| Interstitial Lung Disease | 55 participants - including pulmonary fibrosis pneumoconiosis, asbestosis, sarcoidosis, amyloidosis Receives: Device: N-Tidal C handset | |
| Long COVID | 55 participants Receives: Device: N-Tidal C handset | |
| Upper airway obstruction disorder | 55 participants Receives: Device: N-Tidal C handset | |
| Healthy | 55 participants - with no previous or current chronic cardiorespiratory diagnoses Receives: Device: N-Tidal C handset |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months from First Patient First Visit (FPFV)
Secondary outcomes (9)
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
Measured: 12 months from First Patient First Visit (FPFV)
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
Measured: 12 months from First Patient First Visit (FPFV)
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
Measured: 12 months from First Patient First Visit (FPFV)
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
Measured: 12 months from First Patient First Visit (FPFV)
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
Measured: 12 months from First Patient First Visit (FPFV)
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
Measured: 12 months from First Patient First Visit (FPFV)
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
Measured: 12 months from First Patient First Visit (FPFV)
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
Measured: 12 months from First Patient First Visit (FPFV)
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
Measured: 12 months from First Patient First Visit (FPFV)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start2 Jun 2021
- Primary completion2 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 744 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- TidalSense
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovate UK, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Zishan Ali, MBBS BSc, Principal investigator, Modality PartnershipElango Vijaykumar, MBBS, FRCG, Principal investigator, Modality Partnership
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939558
- Sponsor's protocol ID
- G001-21
- Acronym
- CARES
- Status last verified
- May 2023
- First submitted
- 3 Jun 2021
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lim RH, Talker L, Broomfield H, Dogan C, Selim AB, Lambert G, Carter JC, Neville DM, Wiffen L, Brown T; BRS Team; Vijaykumar E, Chauhan AJ, Patel AX. Quantification of smoking-related airway remodelling in COPD, using N-Tidal. Sci Rep. 2026 Feb 26;16(1):8713. doi: 10.1038/s41598-026-41699-6.
PubMed 41748706
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04939558
- Acronym / sponsor ID
- CARES / G001-21
- Conditions
- COPD, Asthma, Lung Cancer, Anemia, Congestive Cardiac Failure, Bronchiectasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 744 participants (actual)
- Lead sponsor
- TidalSenseIndustry (pharma, biotech, devices)
- Collaborators
- Innovate UK, National Institute for Health Research, United Kingdom
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | – | Device: N-Tidal C handset245 participants - GOLD 1, 2, 3 / A, B, C |
| Asthma | – | Device: N-Tidal C handset55 participants - Mild to moderate, not labelled as severe. |
| Congestive cardiac failure | – | Device: N-Tidal C handset55 participants |
| Anaemia | – | Device: N-Tidal C handset55 participants - with at least 50% of participants recruited having no history of chronic cardiorespiratory conditions |
| Bronchiectasis | – | Device: N-Tidal C handset55 participants - Acquired or genetic, e.g. cystic fibrosis or other primary ciliary dyskinesias |
| Lung cancer | – | Device: N-Tidal C handset55 participants - including rare types e.g. mesothelioma |
| Interstitial Lung Disease | – | Device: N-Tidal C handset55 participants - including pulmonary fibrosis pneumoconiosis, asbestosis, sarcoidosis, amyloidosis |
| Long COVID | – | Device: N-Tidal C handset55 participants |
| Upper airway obstruction disorder | – | Device: N-Tidal C handset55 participants |
| Healthy | – | Device: N-Tidal C handset55 participants - with no previous or current chronic cardiorespiratory diagnoses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- Age > 18 years
- Healthy volunteer (with no previous or current chronic cardiorespiratory diagnoses)
- COPD (GOLD 1, 2, 3 / A, B, C)*
- Asthma (mild to moderate, not labelled as severe)*
- Congestive cardiac failure*
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-Tidal C handsetParticipants 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. | Device | Anaemia, Asthma, Bronchiectasis, Chronic Obstructive Pulmonary Disease, Congestive cardiac failure, Healthy, Interstitial Lung Disease, Long COVID, Lung cancer, Upper airway obstruction disorder |
Primary outcome
Breath records from participants with Chronic Obstructive Pulmonary Disease (COPD)
Time frame: 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
9 secondary outcomes
Breath records from Healthy volunteers (no previous or current cardiorespiratory diagnoses)
Time frame: 12 months from First Patient First Visit (FPFV)
Breath records from participants with Asthma
Time frame: 12 months from First Patient First Visit (FPFV)
Breath records from participants with Congestive cardiac failure
Time frame: 12 months from First Patient First Visit (FPFV)
Breath records from participants with Anaemia
Time frame: 12 months from First Patient First Visit (FPFV)
Breath records from participants with Bronchiectasis
Time frame: 12 months from First Patient First Visit (FPFV)
Breath records from participants with Lung cancer
Time frame: 12 months from First Patient First Visit (FPFV)
Breath records from participants with Interstitial Lung Disease
Time frame: 12 months from First Patient First Visit (FPFV)
Breath records from participants with Long COVID
Time frame: 12 months from First Patient First Visit (FPFV)
Breath records from participants with Upper airway obstruction disorder
Time frame: 12 months from First Patient First Visit (FPFV)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Derived from this study: PubMed 41748706Lim RH, Talker L, Broomfield H, Dogan C, Selim AB, Lambert G, Carter JC, Neville DM, Wiffen L, Brown T; BRS Team; Vijaykumar E, Chauhan AJ, Patel AX. Quantification of smoking-related airway remodelling in COPD, using N-Tidal. Sci Rep. 2026 Feb 26;16(1):8713. doi: 10.1038/s41598-026-41699-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zishan Ali, MBBS BSc principal investigator
Modality Partnership
Elango Vijaykumar, MBBS, FRCG principal investigator
Modality Partnership
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Asthma, run by TidalSense at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breath records from participants with Chronic Obstructive Pulmonary Disease (COPD) (time frame: 12 months from First Patient First Visit (FPFV)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04939558, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.