Clinical Evaluation of a Paediatric Sleep Diagnosis Technology

August 12, 2025 updated by: Acurable Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Patients who are referred to the clinic will spend one night's sleep in the clinic. They will wear a polysomnography system (current goldstandard) and the novel device.

At the end of the trial, we will compare the diagnosis results from both systems.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Sheffield, United Kingdom, S10 2TH
        • Recruiting
        • Sheffield Children Hospital
        • Contact:
        • Principal Investigator:
          • Heather Elphick
      • Southampton, United Kingdom
        • Recruiting
        • Southampton Children's Hospital
        • Contact:
          • Orsina Dessi
        • Principal Investigator:
          • Hazel Evans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

all children who have been referred for a sleep test.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
test group
Test group will wear PSG
Device: Novel wearable paediatric device
The patient will wear the novel wearable paediatric device at the same time as polysmnography
Novel wearable device
THis group will wear the novel device
Device: Novel wearable paediatric device
The patient will wear the novel wearable paediatric device at the same time as polysmnography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity and sensitivity of novel device
Time Frame: 6 months
specificity and sensitivity of the output of the novel wearable device against polysomnography
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acurable Ltd.

Collaborators

University Hospital Southampton NHS Foundation Trust
Sheffield Children's NHS Foundation Trust

Investigators

  • Study Director: Ruth Kingshott, PhD, Sheffield Children's NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2020

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

July 23, 2019

First Submitted That Met QC Criteria

July 23, 2019

First Posted (Actual)

July 25, 2019

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 269747

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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