Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
Recruiting
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Diagnostic Test: Novel Wearable device
- 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.
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
- Arm && Interventions
Group Intervention Description PSG and novel wearable device Novel Wearable device 75 patients will wear polysomnography at the same time as the Novel wearable device PG and novel wearable device Novel Wearable device 75 patients will wear polygraphy at the same time as the novel wearable device
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital Virgen Macarena Sevilla
🇪🇸Seville, Spain