Clinical Evaluation of a Paediatric Sleep Diagnosis Technology

Acurable

Status

Enrolling

Conditions

Sleep Apnea

Treatments

Device: Novel wearable paediatric device

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04031950

269747

Details and patient eligibility

About

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.

Full 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.

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.

Enrollment

200 estimated patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

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