Central Apnoea Monitor Study

NCT06093347 | Withdrawn

• 1 other identifier: SCH-2708
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• The accuracy of the system in 15 patients, when compared with the gold standard measurement system

  24 hours

• The acceptability of the sensor to the child as viewed by the parent (and child)

  As measured by researcher designed questionnaire

  End of study

Eligibility Criteria

• Age: 1 Month - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children admitted to the Sleep Unit at Sheffield Children's Hospital with suspected sleep apnoea

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead
• Sheffield Hallam University: collaborator

Study Sites (1)

Clinical Research Facility, Sheffield Children's Hospital

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 23, 2023
• Study Start: September 18, 2023
• Primary Completion: March 19, 2025
• Study Completion: March 19, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)