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Central Apnoea Monitor Study

Feasibility Study to Evaluate a New Wearable Wireless Device for Monitoring Central Apnoeas in Infants and Children

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06093347
Enrollment
0
Registered
2023-10-23
Start date
2023-09-18
Completion date
2025-03-19
Last updated
2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

Brief summary

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.

Interventions

None listed

Sponsors

Sheffield Children's NHS Foundation Trust
Lead SponsorOTHER
Sheffield Hallam University
CollaboratorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
1 Months to 5 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
The accuracy of the system in 15 patients, when compared with the gold standard measurement system24 hours
The acceptability of the sensor to the child as viewed by the parent (and child)End of studyAs measured by researcher designed questionnaire

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026