At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Novel wearable paediatric device (device)
- How long the study runs
- Study runs about 70 months (dates as stated)
- About the drug or intervention
- Novel wearable paediatric device — device: The patient will wear the novel wearable paediatric device at the same time as polysmnography
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 1 Year to 18 Years
- Who
- All
- Number of participants
- 200
- Started
- 2020-02-19
- Last checked
- 2025-07
Plain English Summary
What is this study?
- • Testing a new treatment for sleep apnea
- • Clinical study - 200 participants
- • 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
Who can take part?
- • Ages 1 Year to 18 Years
- • Diagnosed with sleep apnea
Where?
- • Sheffield - Sheffield Children Hospital
- • Southampton - Southampton Children's Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 1 Year - 18 Years
- Who can join: All genders
What the study is looking for
- ✓Children older than one year old
- ✓Children who have been referred to a sleep clinic due to suspicion of sleep apnoea.
Who cannot take part
- ✗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
See the full criteria
Where Is This Study? (2 UK sites)
Sheffield Children Hospital
Sheffield S10 2TH, United Kingdom
Southampton Children's Hospital
Southampton, United Kingdom
How to Get in Touch
Orsina Dessi, MEng
Sponsor contactCONTACT