Actively Recruiting
Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
Led by Acurable Ltd. · Updated on 2025-08-15
200
Participants Needed
2
Research Sites
8 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
Researchers are evaluating a new system to detect sleep apnea in children. This study focuses on children referred to a sleep clinic because of suspected sleep apnea. The goal is to compare the new detection system's results with those from the current standard test called polysomnography. During the study, children will spend one night at the clinic wearing both the standard polysomnography equipment and the new wearable device designed for pediatric use. The study will compare the diagnosis results from both systems to see how well the new device works. Participants will have their sleep monitored overnight, wearing both devices simultaneously. Researchers will collect data and later compare the sensitivity and specificity of the new device over six months. The total involvement includes this single in-clinic overnight stay and follow-up to analyze the results.
CONDITIONS
Brief Title
Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children older than one year old
- Children referred to a sleep clinic for suspected sleep apnea
You will not qualify if you...
- Parents or guardians not fluent in English or with special communication needs
- Known allergy to adhesive dressing
- Physical or mental impairments causing distress with additional sensors
- Not enough space on the neck area to fit the sensor
- Skin condition or clinical problem in the device attachment area
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 1 night
Participants spend one night in the clinic wearing both the standard polysomnography system and the novel wearable paediatric device for sleep apnea diagnosis.
1 overnight visit (in-person)
Duration - 6 months
Researchers compare the diagnosis results from both systems over a period of 6 months.
No additional visits required; remote data analysis
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
Research Team
O
Orsina Dessi, MEng
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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