NCT04031950 Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
| NCT ID | NCT04031950 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Acurable Ltd. |
| Condition | Sleep Apnea |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2020-02-19 |
| Primary Completion | 2025-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2020-02-19 with a primary completion date of 2025-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Ruth Kingshott, PhD
STUDY DIRECTOR
Sheffield Children's NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT04031950 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04031950 currently recruiting?
Yes, NCT04031950 is actively recruiting participants. Contact the research team at orsina@acurable.com for enrollment information.
Where is the NCT04031950 trial being conducted?
This trial is being conducted at Sheffield, United Kingdom, Southampton, United Kingdom.
Who is sponsoring the NCT04031950 clinical trial?
NCT04031950 is sponsored by Acurable Ltd.. The principal investigator is Ruth Kingshott, PhD at Sheffield Children's NHS Foundation Trust. The trial plans to enroll 200 participants.