Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
1 other identifier
observational
200
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2019
CompletedFirst Posted
Study publicly available on registry
July 25, 2019
CompletedStudy Start
First participant enrolled
February 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedAugust 15, 2025
July 1, 2025
5.7 years
July 23, 2019
August 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Specificity and sensitivity of novel device
specificity and sensitivity of the output of the novel wearable device against polysomnography
6 months
Study Arms (2)
test group
Test group will wear PSG
Novel wearable device
THis group will wear the novel device
Interventions
The patient will wear the novel wearable paediatric device at the same time as polysmnography
Eligibility Criteria
all children who have been referred for a sleep test.
You may qualify if:
- Children older than one year old
- Children who have been referred to a sleep clinic due to suspicion of sleep apnoea.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acurable Ltd.lead
- Sheffield Children's NHS Foundation Trustcollaborator
- University Hospital Southampton NHS Foundation Trustcollaborator
Study Sites (2)
Sheffield Children Hospital
Sheffield, S10 2TH, United Kingdom
Southampton Children's Hospital
Southampton, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ruth Kingshott, PhD
Sheffield Children's NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2019
First Posted
July 25, 2019
Study Start
February 19, 2020
Primary Completion
October 30, 2025
Study Completion
December 30, 2025
Last Updated
August 15, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share