Status:
UNKNOWN
AcuPebble to Remotely Monitor Patients With OSA on CPAP Therapy
Lead Sponsor:
Royal Free Hospital NHS Foundation Trust
Collaborating Sponsors:
Acurable Ltd.
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18-80 years
Brief Summary
Obstructive sleep apnoea (OSA) is a breathing problem that happens when you sleep. It is treated by a machine called continuous positive airway pressure (CPAP) therapy. The goal of this observational...
Detailed Description
Obstructive sleep apnoea (OSA) affects almost one billion people globally and can lead to numerous health consequences including ischaemic heart disease, hypertension, stroke and arrhythmias. It also ...
Eligibility Criteria
Inclusion
- Patients with an initial diagnosis of moderate/severe OSA (AHI ≥ 15events/hr made on full polysomnography, cardiorespiratory-polygraphy or other validated home sleep study) with no evidence of hypoventilation
- Patients who have been established on CPAP therapy for \> 3months
- Patients who are deemed compliant on CPAP therapy (average use ≥ 4 hours/night for ≥ 70% of the last 28 days)
Exclusion
- Age \<18
- Subjects not fluent in English, or who have special communication needs
- Known allergy to adhesive dressing
- Subjects with physical or mental impairments who would not be able to use the device and technology on their own
- Subjects with implantable devices
- Subjects with stridor
- Subjects unable to give consent
- Subjects on non-invasive ventilation (NIV) or bi-level positive airway pressure (BIPAP)
Key Trial Info
Start Date :
October 7 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06097949
Start Date
October 7 2022
End Date
February 1 2024
Last Update
October 24 2023
Active Locations (1)
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1
Academic Respiratory Department Royal Free Hospital NHS Foundation Trust
London, United Kingdom