Actively Recruiting

Age: 1Year - 18Years
All Genders
NCT04031950

Clinical Evaluation of a Paediatric Sleep Diagnosis Technology

Led by Acurable Ltd. · Updated on 2025-08-15

200

Participants Needed

2

Research Sites

305 weeks

Total Duration

On this page

Sponsors

A

Acurable Ltd.

Lead Sponsor

S

Sheffield Children's NHS Foundation Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Clinical Evaluation of a Paediatric Sleep Diagnosis Technology

Who Can Participate

Age: 1Year - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children older than one year old
  • Children who have been referred to a sleep clinic due to suspicion of sleep apnoea.
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Sheffield Children Hospital

Sheffield, United Kingdom, S10 2TH

Actively Recruiting

2

Southampton Children's Hospital

Southampton, United Kingdom

Actively Recruiting

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Research Team

O

Orsina Dessi, MEng

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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