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Recruiting

NCT Number: NCT04031950

Clinical Evaluation of a Paediatric Sleep Diagnosis Technology

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.

Recruiting

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sheffield Children Hospital, Sheffield, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novel wearable paediatric device

Device

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

Primary outcomes

  1. Specificity and sensitivity of novel device

    Time frame: 6 months

    specificity and sensitivity of the output of the novel wearable device against polysomnography

Study contacts

Contact information is provided by the study sponsor or research team.

Orsina Dessi, MEng

CONTACT

[email protected]

+447721 877020

Sponsors and collaborators

Lead sponsor

Acurable Ltd.

Industry

Collaborators

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

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2019
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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