Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea

Acurable

Status: Enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Diagnostic Test: Novel Wearable device

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04028011

720/19/EC

Details and patient eligibility

About

This trial will aim to test a new wearable device for the diagnosis of Sleep Apnoea.

Full description

This clinical trial will test a new wearable device for the diagnosis of Sleep Apnoea against Multi-channel polygraphy and Polysomnography.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have been referred to a sleep clinic due to suspicion of sleep apnoea.
• patients between the age of 18 yo and 80 yo

Exclusion criteria

• who are not fluent in Spanish, or who have special communication needs.
• Known allergy to the adhesive dressing.
• patients with physical or mental impairments who would not be able to use the new technology on their own.
• patients with very loose/saggy skin in the neck area which would unavoidably result on AcuPebble swinging if moving the neck.
• patients with pacemakers or who have any type of implanted electronic device

Trial design

150 participants in 2 patient groups

PSG and novel wearable device

Description:

75 patients will wear polysomnography at the same time as the Novel wearable device

Treatment:

Diagnostic Test: Novel Wearable device

PG and novel wearable device

Description:

75 patients will wear polygraphy at the same time as the novel wearable device

Treatment:

Diagnostic Test: Novel Wearable device