Heart Rate MeasurementsNCT06093373
The Doppler Feasibility Study
An observational study of Heart Rate Measurements, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The study is an exploratory research study looking at the feasibility, acceptability and accuracy of a doppler device compared with the gold standard ECG. It will take place in the sleep unit at Sheffield Children's Hospital. Read more about this study
- Who is it for?
- Ages 1 month to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Measurements
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 May 2023to 29 Dec 2023
- 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 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 1-12 months admitted to the Sleep Unit at Sheffield Children's Hospital
Who may be able to join
- Patients who have been referred for a cardio-respiratory polygraphy sleep study.
- Patients aged one month up to one year old.
Who cannot join
- Subjects whose parents/legal guardians/carers are not fluent in English, or who have special communication needs.
- Child anticipated to become distressed with additional sensor.
- Child too clinically unwell to take part (as decided by clinical staff).
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: Feasibility Study to Evaluate a New Hands-free Doppler Heart Rate Monitor Normally Used to Measure the Fetal Heart Rate
The study is an exploratory research study looking at the feasibility, acceptability and accuracy of a doppler device compared with the gold standard ECG. It will take place in the sleep unit at Sheffield Children's Hospital.
- Conditions
- Heart Rate Measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Comparison | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of the system in 15 patients, when compared with the gold standard ECG
Measured: 1 hour
The acceptability of the sensor to the child as viewed by the parent
As measured by researcher designed questionnaire
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start19 May 2023
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate MeasurementsStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Hallam University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093373
- Sponsor's protocol ID
- SCH-2798
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Evaluate a New Hands-free Doppler Heart Rate Monitor Normally Used to Measure the Fetal Heart Rate
- ClinicalTrials.gov ID
- NCT06093373
- Acronym / sponsor ID
- SCH-2798
- Conditions
- Heart Rate Measurements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Sheffield Hallam University
- Study start
- 19 May 2023 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 23 Oct 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.
The study is an exploratory research study looking at the feasibility, acceptability and accuracy of a doppler device compared with the gold standard ECG. It will take place in the sleep unit at Sheffield Children's Hospital.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparison | – | – |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 1-12 months admitted to the Sleep Unit at Sheffield Children's Hospital
Key inclusion criteria (2 listed)
- Patients who have been referred for a cardio-respiratory polygraphy sleep study.
- Patients aged one month up to one year old.
Key exclusion criteria (3 listed)
- Subjects whose parents/legal guardians/carers are not fluent in English, or who have special communication needs.
- Child anticipated to become distressed with additional sensor.
- Child too clinically unwell to take part (as decided by clinical staff).
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
The accuracy of the system in 15 patients, when compared with the gold standard ECG
Time frame: 1 hour
The acceptability of the sensor to the child as viewed by the parent
Time frame: 1 hour
As measured by researcher designed questionnaire
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 17 Apr 2024.
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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 Heart Rate Measurements, 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 2 inclusion and 3 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 17 Apr 2024. 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?
The accuracy of the system in 15 patients, when compared with the gold standard ECG (time frame: 1 hour). 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 17 Apr 2024.