Sleep Apnea Syndromes in ChildrenNCT03823326
Paediatric Oximetry Algorithms - Normative Data Collection
An observational study of Sleep Apnea Syndromes in Children, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
To undertake normative data collection of existing clinical algorithms using existing oximetry technology. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Sleep Apnea Syndromes in Children
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 May 2017to 1 Apr 2018
- 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 1 month to 16 years
- All sexes
- Child
Study population: All children aged 1 month - 16 years who are undergoing an overnight pulse oximetry investigation.
Who may be able to join
- All children who have been referred for a clinical overnight pulse oximetry test
Who cannot join
- Families who do not understand written English if an interpreter is not present for clinical reasons
- Times when the kit is already being used for another recruit
- If children do not attend with the legal guardian and so informed consent cannot be signed
- Patient is deemed too unwell by clinical team to be approached about the research
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Research Facility
Sheffield, South Yorkshire, S10 2TH
About this study
To undertake normative data collection of existing clinical algorithms using existing oximetry technology.
Read the detailed description
Paediatric patients who are undergoing routine diagnostic pulse oximetry, will be approached to also wear an additional oximeter at the same time so that comparisons between two oximeters and their clinical algorithms can be compared.
- Conditions
- Sleep Apnea Syndromes in Children
What is being measured
The primary outcome is the main question the study is designed to answer.
Oximetry Raw data
2 second data dumps of SpO2 signals from an overnight trace
Measured: Overnight (8-10 hours) of pulse oximetry data is collected from participants and then they have completed the study. It is a single time frame of data collection.
Pulse Rate Raw data
2 second data dumps of SpO2 signals from an overnight trace
Measured: Overnight (8-10 hours) of pulse oximetry data is collected from participants and then they have completed the study. It is a single time frame of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start26 May 2017
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea Syndromes in ChildrenStudies 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather E Elphick, MbChBMDMRCPH, Principal investigator, Sheffield Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823326
- Sponsor's protocol ID
- SCH-2155
- Status last verified
- Jan 2019
- First submitted
- 25 Jan 2019
- Last updated
- 30 Jan 2019
- 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 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paediatric Oximetry Algorithms - Normative Data Collection
- ClinicalTrials.gov ID
- NCT03823326
- Acronym / sponsor ID
- SCH-2155
- Conditions
- Sleep Apnea Syndromes in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 26 May 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 30 Jan 2019 (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.
To undertake normative data collection of existing clinical algorithms using existing oximetry technology.
Detailed description
Paediatric patients who are undergoing routine diagnostic pulse oximetry, will be approached to also wear an additional oximeter at the same time so that comparisons between two oximeters and their clinical algorithms can be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- All children aged 1 month - 16 years who are undergoing an overnight pulse oximetry investigation.
Key inclusion criteria (1 listed)
- All children who have been referred for a clinical overnight pulse oximetry test
Key exclusion criteria (4 listed)
- Families who do not understand written English if an interpreter is not present for clinical reasons
- Times when the kit is already being used for another recruit
- If children do not attend with the legal guardian and so informed consent cannot be signed
- Patient is deemed too unwell by clinical team to be approached about the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oximetry Raw data
Time frame: Overnight (8-10 hours) of pulse oximetry data is collected from participants and then they have completed the study. It is a single time frame of data collection.
2 second data dumps of SpO2 signals from an overnight trace
Pulse Rate Raw data
Time frame: Overnight (8-10 hours) of pulse oximetry data is collected from participants and then they have completed the study. It is a single time frame of data collection
2 second data dumps of SpO2 signals from an overnight trace
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 30 Jan 2019.
- 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.
Heather E Elphick, MbChBMDMRCPH principal investigator
Sheffield Children's Hospital
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 Sleep Apnea Syndromes in Children, 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 1 inclusion and 4 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 30 Jan 2019. 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?
Oximetry Raw data (time frame: Overnight (8-10 hours) of pulse oximetry data is collected from participants and then they have completed the study. It is a single time frame of data collection.). The study lists 2 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 30 Jan 2019.