Evaluating a new sleep apnea detection device for children
Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
This study is testing a new device to see if it can effectively detect sleep apnea in children compared to the standard sleep test.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Acurable Ltd. Industry-sponsored |
| Locations | 2 sites (Sheffield and 1 other locations) |
| Trial ID | NCT04031950 on ClinicalTrials.gov |
What this trial studies
This project aims to collect data and assess algorithms to evaluate the clinical effectiveness of a novel sleep apnea detection system specifically designed for children. Patients referred for suspected sleep apnea will participate by spending a night in the clinic, where they will use both the new device and the standard polysomnography system. The study will compare the diagnostic results from both systems to determine the efficacy of the novel device in diagnosing sleep apnea in the pediatric population.
Who should consider this trial
Good fit: Ideal candidates for this study are children older than one year who have been referred to a sleep clinic due to suspected sleep apnea.
Not a fit: Patients who may not benefit from this study include those with communication barriers, allergies to adhesives, or physical/mental impairments that would prevent them from using the device.
Why it matters
Potential benefit: If successful, this study could lead to a more effective and accessible method for diagnosing sleep apnea in children.
How similar studies have performed: Other studies have shown promise in using novel devices for sleep apnea detection, but this specific approach in the pediatric population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children older than one year old * Children who have been referred to a sleep clinic due to suspicion of sleep apnoea. Exclusion Criteria: * Patients whose parents/legal guardians/carers are not fluent in English, or who have special communication needs. * Known allergy to the adhesive dressing. * Patients with physical or mental impairments who would be too distressed with additional sensors on themselves. * Patients with not enough space on the neck area to fit the sensor. * Clinical problem in the area in which the device will be attached, eg skin condition
Where this trial is running
Sheffield and 1 other locations
- Sheffield Children Hospital — Sheffield, United Kingdom (Recruiting)
- Southampton Children's Hospital — Southampton, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Orsina Dessi, MEng
- Email: orsina@acurable.com
- Phone: +447721 877020
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.