Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sleep Apnea
- Sponsor
- Acurable Ltd.
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Specificity and sensitivity of novel device
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
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.
Investigators
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
Outcomes
Primary Outcomes
Specificity and sensitivity of novel device
Time Frame: 6 months
specificity and sensitivity of the output of the novel wearable device against polysomnography