Clinical Evaluation of a Paediatric Sleep Diagnosis Technology

Sleep Apnea Clinical Trial

Official title:

Clinical Evaluation of a Paediatric Sleep Diagnosis Technology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04031950
• Other study ID #: 269747
• Status: Recruiting
• Start date: February 19, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2023
• Source: Acurable Ltd.
• Contact: Orsina Dessi, MEng
• Phone: +447721 877020
• Email: orsina[@]acurable.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• Novel wearable paediatric device
The patient will wear the novel wearable paediatric device at the same time as polysmnography

Locations

Country	Name	City	State
United Kingdom	Sheffield Children Hospital	Sheffield
United Kingdom	Southampton Children's Hospital	Southampton

Sponsors (3)

Lead Sponsor	Collaborator
Acurable Ltd.	Sheffield Children's NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specificity and sensitivity of novel device	specificity and sensitivity of the output of the novel wearable device against polysomnography	6 months