Clinical trial Recruiting at 2 sites Observational Ages 1 Year to 18

Evaluating a new sleep apnea detection device for children

Official title: Clinical Evaluation of a Paediatric Sleep Diagnosis Technology

Run by Acurable Ltd. · NCT04031950 · Data updated 2026-11-12

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 typeObservational
Ages1 Year to 18 Years
SexAll
Enrollment200 (estimated)
SponsorAcurable Ltd.
Industry-sponsored
Locations2 sites (Sheffield and 1 other locations)
StatusRecruiting
StartedFebruary 19, 2020
Main results expectedOctober 30, 2025
Study endsDecember 30, 2025
Registry record updatedAugust 15, 2025
Trial IDNCT04031950 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies have shown promise in using novel devices for sleep apnea detection, but this specific approach in the pediatric population is relatively novel.

Who can join: the full rules

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 it's running

  • Sheffield Children Hospital
    Sheffield, United Kingdom
    Recruiting
  • Southampton Children's Hospital
    Southampton, United Kingdom
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.