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Recruiting Observational

Clinical Evaluation of a Paediatric Sleep Diagnosis Technology

NCT04031950 · tracked via the Priya Life Science UK tracker
Sponsor
Acurable Ltd
Phase
Observational
Started
2020-02-19
Last updated
2025-08-15

Condition(s) studied

Sleep Apnea

Investigational drug(s) / intervention(s)

Novel wearable paediatric device

Novel wearable paediatric device: The patient will wear the novel wearable paediatric device at the same time as polysmnography

Study summary

The objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population.

The Study will involve patients who will have been referred for diagnosis of sleep apnoea, and the ultimate aim will be to compare the output of a novel apnoea detection system against in -clinic polysomnography.

Eligibility

Sex
ALL
Min age
1 Year
Max age
18 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Specificity and sensitivity of novel device — 6 months
    specificity and sensitivity of the output of the novel wearable device against polysomnography

Trial sites (2)

FacilityCityRegionStatus
Sheffield Children Hospital Sheffield United Kingdom Recruiting
Southampton Children's Hospital Southampton United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04031950 on ClinicalTrials.gov ↗ ← All trials in the UK