Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
NCT ID: NCT04031950
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2020-02-19
2025-12-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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test group
Test group will wear PSG
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
Novel wearable paediatric device
The patient will wear the novel wearable paediatric device at the same time as polysmnography
Interventions
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Novel wearable paediatric device
The patient will wear the novel wearable paediatric device at the same time as polysmnography
Eligibility Criteria
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Inclusion Criteria
* Children who have been referred to a sleep clinic due to suspicion of sleep apnoea.
Exclusion Criteria
* 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
1 Year
18 Years
ALL
No
Sponsors
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Sheffield Children's NHS Foundation Trust
OTHER
University Hospital Southampton NHS Foundation Trust
OTHER
Acurable Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ruth Kingshott, PhD
Role: STUDY_DIRECTOR
Sheffield Children's NHS Foundation Trust
Locations
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Sheffield Children Hospital
Sheffield, , United Kingdom
Southampton Children's Hospital
Southampton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Orsina Dessi
Role: primary
Other Identifiers
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269747
Identifier Type: -
Identifier Source: org_study_id
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