Asthma in ChildrenN-WATCHNCT07833826
N-WATCH: Nottingham Wheeze Assessment in Tidal Children
An observational study of Asthma in Children, run by University of Nottingham at 2 sites in United Kingdom.
Trial summary
Children with long-term lung diseases like asthma need better techniques for diagnosis and monitoring of their disease. With better monitoring, it is anticipated that children and their carers will be able to manage their disease better, and be able to spot a deterioration in their condition sooner, leading to earlier… Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children
- What is being tested?
- N-Tidal
- How many people
- 340 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 15 Jul 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with asthma wheeze either acutely unwell or attending for lung function testing.
Workstream 1 inclusion criteria i) Aged 5 years or older, and less than 15 years plus 32 weeks of age ii) Participant has presented to hospital with acute wheeze, bronchospasm or asthma iii) Participant is not critically ill and is able to breathe into a mouthpiece for 90seconds.
Workstream 2 inclusion criteria i) Participant 5 years or older, and less than 16 years of age. ii) Participant is due to have routine lung function testing.
Exclusion criteria i) Life threatening respiratory difficulties (defined as cyanosis, oxygen saturations less than 92% despite oxygen supplementation, silent chest on auscultation, poor respiratory effort, fatigue or exhaustion, agitation or reduced level of consciousness) ii) Participation in another research project whose protocol prevents participation in this project.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG7 2UH
Andrew P Prayle, BMBS, +44 115 8230623, andrew.prayle@nottingham.ac.uk
- Recruiting
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG7 2UH
Andrew P Prayle, 07764758506, andrew.prayle@nottingham.ac.uk
About this study
Children with long-term lung diseases like asthma need better techniques for diagnosis and monitoring of their disease. With better monitoring, it is anticipated that children and their carers will be able to manage their disease better, and be able to spot a deterioration in their condition sooner, leading to earlier intervention, for example to prevent an asthma attack.
However, current devices which could be used at home are either too costly, require machines that are impractically large, or require specific breathing maneuvers which are unpopular with patients, or which are difficult for younger children to perform. There is a need for better devices.
Read more
The N-Tidal C is a CE Marked medical device which measures exhaled carbon dioxide levels accurately. Early work in its use in adult diseases such as Chronic Obstructive Pulmonary Disease indicates that the device can detect altered lung function associated with disease.
This device has several attractive properties for children - it is small, easy to use, and does not require specific breathing maneuvers - just normal breathing.
Based on data from a small feasibility study, the study investigators believe that this device will be useful in children. Young children can use it with minimal instruction. Parents and children have reported that it is easy to use.
The investigators do not yet have sufficient feasibility information required to plan a larger study, such as deciding how many children the future study will need to recruit, or knowing how well the measurements made with the device agree with standard lung function tests.
In this work, the investigators are conducting a feasibility study to determine the number of children needed for a larger trial and to explore how well the N-Tidal C device measurements compare with standard lung function tests. Data from this study will be used to plan future larger studies of the device in children with respiratory diseases.
- Conditions
- Asthma in Children
- Being tested
- N-Tidal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-TidalDiagnostic test
Capnometry
| Study group | Role | What they receive |
|---|---|---|
| Acute wheeze - feasibility | Children aged 5 - to less than 16 with acute wheeze admitted to hospital. Receives: Diagnostic Test: N-Tidal | |
| Lung function cohort - feasibility | Children aged 5 to less than 16 with a planned pulmonary function test measurement Receives: Diagnostic Test: N-Tidal | |
| Acute wheeze - main study | Children aged 5 years and less than 16 years admitted with acute wheeze or asthma | |
| Lung function cohort - main study | Children aged 5 years and above attending for routine outpatient lung function testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Percentage (%) of patients approached who enrol in the study
Feasibility criteria
Measured: At recruitment. Participants will be given at least 24 hours to consider whether they would like to enrol in the study. If they have not enrolled in the study within 7 completed days, they will have been approached but not enrolled.
Secondary outcomes (2)
1. Proportion (%) of participants who successfully complete a set of capnograms (before and after bronchodilator).
To meet this criteria enrolled participants have a capnogram meeting study SOP defined quality control metrics before and after bronchodilator.
Measured: From enrolment to end of hospital inpatient stay. This will be through study completion, average of 7 days or less.
2. Proportion (%) of participants who return for a follow up visit
Enrolled participants will be invited back to have a follow up capnogram in a window from 8 - 16 weeks after consent. If they attend the follow up visit they will meet this study endpoint criteria.
Measured: 16 weeks from consent (i.e. less than 16 weeks and 1 day).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start15 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833826
- Sponsor's protocol ID
- 24023
- Other IDs
- 342058
- Acronym
- N-WATCH
- Status last verified
- Sep 2026
- First submitted
- 24 Jun 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-WATCH: Nottingham Wheeze Assessment in Tidal Children
- ClinicalTrials.gov ID
- NCT07833826
- Acronym / sponsor ID
- N-WATCH / 24023
- Conditions
- Asthma in Children
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Sep 2026 (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.
Children with long-term lung diseases like asthma need better techniques for diagnosis and monitoring of their disease. With better monitoring, it is anticipated that children and their carers will be able to manage their disease better, and be able to spot a deterioration in their condition sooner, leading to earlier intervention, for example to prevent an asthma attack.
However, current devices which could be used at home are either too costly, require machines that are impractically large, or require specific breathing maneuvers which are unpopular with patients, or which are difficult for younger children to perform. There is a need for better devices.
The N-Tidal C is a CE Marked medical device which measures exhaled carbon dioxide levels accurately. Early work in its use in adult diseases such as Chronic Obstructive Pulmonary Disease indicates that the device can detect altered lung function associated with disease.
This device has several attractive properties for children - it is small, easy to use, and does not require specific breathing maneuvers - just normal breathing.
Based on data from a small feasibility study, the study investigators believe that this device will be useful in children. Young children can use it with minimal instruction. Parents and children have reported that it is easy to use.
The investigators do not yet have sufficient feasibility information required to plan a larger study, such as deciding how many children the future study will need to recruit, or knowing how well the measurements made with the device agree with standard lung function tests.
In this work, the investigators are conducting a feasibility study to determine the number of children needed for a larger trial and to explore how well the N-Tidal C device measurements compare with standard lung function tests. Data from this study will be used to plan future larger studies of the device in children with respiratory diseases.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acute wheeze - feasibility | – | Diagnostic Test: N-TidalChildren aged 5 - to less than 16 with acute wheeze admitted to hospital. |
| Lung function cohort - feasibility | – | Diagnostic Test: N-TidalChildren aged 5 to less than 16 with a planned pulmonary function test measurement |
| Acute wheeze - main study | – | –Children aged 5 years and less than 16 years admitted with acute wheeze or asthma |
| Lung function cohort - main study | – | –Children aged 5 years and above attending for routine outpatient lung function testing |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with asthma wheeze either acutely unwell or attending for lung function testing.
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-TidalCapnometry | Diagnostic test | Acute wheeze - feasibility, Lung function cohort - feasibility |
Primary outcome
1. Percentage (%) of patients approached who enrol in the study
Time frame: At recruitment. Participants will be given at least 24 hours to consider whether they would like to enrol in the study. If they have not enrolled in the study within 7 completed days, they will have been approached but not enrolled.
Feasibility criteria
2 secondary outcomes
1. Proportion (%) of participants who successfully complete a set of capnograms (before and after bronchodilator).
Time frame: From enrolment to end of hospital inpatient stay. This will be through study completion, average of 7 days or less.
2. Proportion (%) of participants who return for a follow up visit
Time frame: 16 weeks from consent (i.e. less than 16 weeks and 1 day).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Asthma in Children
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Not yet recruiting
Artificially Intelligent Robot Control
Asthma in Children, Artificial Intelligence
Not yet recruiting
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Pediatric Asthma, Acute Asthma
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children, run by University of Nottingham at 2 sites 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?
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: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew P Prayle, BMBS (+44 (0) 115 9249924, andrew.prayle@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Percentage (%) of patients approached who enrol in the study (time frame: At recruitment. Participants will be given at least 24 hours to consider whether they would like to enrol in the study. If they have not enrolled in the study within 7 completed days, they will have been approached but not enrolled.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2026.