The Doppler Feasibility Study

NCT ID: NCT06093373

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-19

Study Completion Date

2023-12-29

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Rate Measurements

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Comparison

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients who have been referred for a cardio-respiratory polygraphy sleep study.
* Patients aged one month up to one year old.

Exclusion Criteria

* 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).
Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheffield Hallam University

OTHER

Sponsor Role collaborator

Sheffield Children's NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Research Facility, Sheffield Children's Hospital

Sheffield, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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SCH-2798

Identifier Type: -

Identifier Source: org_study_id

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