Monitoring central sleep apnoea in children
Feasibility Study to Evaluate a New Wearable Wireless Device for Monitoring Central Apnoeas in Infants and Children
Sheffield Children's NHS Foundation Trust · NCT06093347
This study is testing a new monitor for central sleep apnoea in children to see if it works better than the current methods used in sleep studies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 1 Month to 5 Years |
| Sex | All |
| Sponsor | Sheffield Children's NHS Foundation Trust (other) |
| Locations | 1 site (Sheffield) |
| Trial ID | NCT06093347 on ClinicalTrials.gov |
What this trial studies
This observational study involves 15 children who are being evaluated for central sleep apnoea at Sheffield Children's Hospital. A new central apnoea monitor will be placed around the child's abdomen overnight, alongside existing sensors used in clinical sleep studies. The aim is to compare the signals from both systems to assess the accuracy of the new device in detecting central sleep apnoea.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 month to 5 years who have been referred for a cardio-respiratory polygraphy sleep study.
Not a fit: Patients who are not fluent in English or have special communication needs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing central sleep apnoea in young children.
How similar studies have performed: While this approach is novel, similar studies have shown promise in improving diagnostic accuracy for sleep-related disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Sheffield
- Clinical Research Facility, Sheffield Children's Hospital — Sheffield, United Kingdom (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sleep Apnea