Status:
RECRUITING
Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
Lead Sponsor:
Acurable Ltd.
Collaborating Sponsors:
Hospital Universitario Virgen Macarena
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-80 years
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 30 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04028011
Start Date
September 30 2019
End Date
December 30 2024
Last Update
April 17 2024
Active Locations (1)
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1
Hospital Virgen Macarena Sevilla
Seville, Spain