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

Recruiting

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT04028011
• Lead Sponsor: Acurable Ltd.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2019-07-18
• Study First Submitted QC: 2019-07-19
• Study First Posted: 2019-07-22
• Study Start: 2019-09-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivities and Specificity for diagnosis of sleep apnoea studies with novel wearable device	6 months	The study aims to compare the diagnosis result of the novel wearable device against standard of care

Trial Locations

Locations (1)

Hospital Virgen Macarena Sevilla; 🇪🇸 Seville, Spain