Central Apnoea Monitor Study

NCT ID: NCT06093347

Last Updated: 2023-10-23

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

UNKNOWN

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-18

Study Completion Date

2024-06-30

Brief Summary

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An initial small study on 15 children that are already being investigated for central sleep apnoea in the sleep unit at Sheffield Children's Hospital. The central apnoea monitor will be placed around the child's abdomen overnight alongside the sensors already being used for the clinical sleep study and the signals from the two systems will be compared to evaluate the accuracy of the new device.

Detailed Description

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Conditions

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Sleep Apnea

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who have been referred for a cardio-respiratory polygraphy sleep study.
* Patients aged 1 month up to 5 years 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

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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 RECRUITING

Countries

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United Kingdom

Facility Contacts

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Heather Elphick

Role: primary

0114 2717000

Other Identifiers

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SCH-2708

Identifier Type: -

Identifier Source: org_study_id

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