Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Novel wearable paediatric device.
- Who it may be relevant to
- Registry conditions: Sleep Apnea. Basic parameters: 1 year — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Device Novel wearable paediatric device
The patient will wear the novel wearable paediatric device at the same time as polysmnography
Primary outcome measures
- Specificity and sensitivity of novel device [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 2 centers
- Sheffield Children Hospital — Sheffield
- Southampton Children's Hospital — Southampton
Identifiers
NCT: NCT04031950 · 269747