Obstructive Sleep Apnea
Conditions
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.
Interventions
DIAGNOSTIC_TESTNovel Wearable device
patient will wear novel wearable device overnight along with normal standard of care
Sponsors
Hospital Universitario Virgen Macarena
Acurable Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Contacts
Primary ContactOrsina Dessi, MEng
Outcome results
None listed