SpirometryNCT05960344
The SPIRO-MOTE Study
An observational study of Spirometry, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Multicentre Prospective Cohort Study of Remote Lung Function Testing in Children: validation and comparison of supervised and unsupervised spirometry Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Spirometry
- What is being tested?
- Spirometry
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Feb 2021to 31 May 2022
- 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 5 to 16 years
- All sexes
- Child
Study population: Participants will be recruited at the four participating centres: Sheffield Children's Hospital, Leeds Children's Hospital, Royal Hospital for Children (Glasgow) and Great Ormond Street Hospital (London).
Who may be able to join
- Male and female children aged 5 to 16 years old
- Doctor diagnosed respiratory condition, including asthma, cystic fibrosis, PCD, bronchiectasis
- Child able to perform reliable spirometry
- Family have access to a smartphone or tablet and a second device for video consultation
Who cannot join
- Significant learning difficulties
- Other reasons for being unable to do lung function tests, for example, unable to make a seal around the mouthpiece
- Informed consent/assent has not been provided
- No English speaking member of the family
- Contraindications as outlined by the ARTP, e.g. pneumothorax, haemoptysis of unknown origin, unstable cardiovascular status, recent eye surgery, vomiting or any acute disease that would interfere with the test performance, recent surgery (thoracic/abdominal)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Research Facility, Sheffield Children's Hospital
Sheffield
About this study
Official title: Multicentre Prospective Cohort Study of Remote Lung Function Testing in Children: Validation and Comparison of Supervised and Unsupervised Spirometry
Multicentre Prospective Cohort Study of Remote Lung Function Testing in Children: validation and comparison of supervised and unsupervised spirometry
- Conditions
- Spirometry
- Being tested
- Spirometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirometryProcedure or surgery
Supervised v unsupervised spirometry
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome measures from spirometry tests (1)
The researchers will use the absolute values for FEV1 and FVC, coupled with the demographic data, to calculate FEV1/FVC, percent predicted and z-scores using a batch calculator from the GLI website. The team will record how many patients achieved technically acceptable tests, using the ATS A-F standards (9), and how many failed.
Measured: Within two weeks
Outcome measures from spirometry tests (2)
The team will record how many patients achieved technically acceptable tests, using the ATS A-F standards (9), and how many failed.
Measured: Within two weeks
Length of each standard test
Researchers will record how long each standard test took to carry out.
Measured: Within two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start24 Feb 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpirometryStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Elphick, Sheffield Children's NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960344
- Sponsor's protocol ID
- SCH-2539
- Status last verified
- Jul 2023
- First submitted
- 19 Apr 2023
- Last updated
- 25 Jul 2023
- Results posted
- 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 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Prospective Cohort Study of Remote Lung Function Testing in Children: Validation and Comparison of Supervised and Unsupervised Spirometry
- ClinicalTrials.gov ID
- NCT05960344
- Acronym / sponsor ID
- SCH-2539
- Conditions
- Spirometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 25 Jul 2023 (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.
Multicentre Prospective Cohort Study of Remote Lung Function Testing in Children: validation and comparison of supervised and unsupervised spirometry
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- Participants will be recruited at the four participating centres: Sheffield Children's Hospital, Leeds Children's Hospital, Royal Hospital for Children (Glasgow) and Great Ormond Street Hospital (London).
Key inclusion criteria (4 listed)
- Male and female children aged 5 to 16 years old
- Doctor diagnosed respiratory condition, including asthma, cystic fibrosis, PCD, bronchiectasis
- Child able to perform reliable spirometry
- Family have access to a smartphone or tablet and a second device for video consultation
Key exclusion criteria (5 listed)
- Significant learning difficulties
- Other reasons for being unable to do lung function tests, for example, unable to make a seal around the mouthpiece
- Informed consent/assent has not been provided
- No English speaking member of the family
- Contraindications as outlined by the ARTP, e.g. pneumothorax, haemoptysis of unknown origin, unstable cardiovascular status, recent eye surgery, vomiting or any acute disease that would interfere with the test performance, recent surgery (thoracic/abdominal)
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 |
|---|---|---|
| SpirometrySupervised v unsupervised spirometry | Procedure or surgery | – |
Primary outcome
Outcome measures from spirometry tests (1)
Time frame: Within two weeks
The researchers will use the absolute values for FEV1 and FVC, coupled with the demographic data, to calculate FEV1/FVC, percent predicted and z-scores using a batch calculator from the GLI website. The team will record how many patients achieved technically acceptable tests, using the ATS A-F standards (9), and how many failed.
Outcome measures from spirometry tests (2)
Time frame: Within two weeks
The team will record how many patients achieved technically acceptable tests, using the ATS A-F standards (9), and how many failed.
Length of each standard test
Time frame: Within two weeks
Researchers will record how long each standard test took to carry out.
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 25 Jul 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Spirometry, run by Sheffield Children's NHS Foundation Trust 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 4 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 25 Jul 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?
Outcome measures from spirometry tests (1) (time frame: Within two weeks). The study lists 3 primary outcomes in all. 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 25 Jul 2023.