Trials / Recruiting
RecruitingNCT04031950
Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Acurable Ltd. · Industry
- Sex
- All
- Age
- 1 Year – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Novel wearable paediatric device | The patient will wear the novel wearable paediatric device at the same time as polysmnography |
Timeline
- Start date
- 2020-02-19
- Primary completion
- 2025-10-30
- Completion
- 2025-12-30
- First posted
- 2019-07-25
- Last updated
- 2025-08-15
Locations
2 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04031950. Inclusion in this directory is not an endorsement.