The Use of a Novel Wearable Medical Device (AcuPebble SA100) to Remotely Monitor Patients With Obstructive Sleep Apnoea (OSA) on Continuous Positive Airway Pressure Therapy (CPAP)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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 trial is to test how well a new wearable device can detect ongoing OSA in patients undergoing treatment with CPAP. The main questions it aims to answer are: 1. Does the new wearable device detect OSA in patients undergoing treatment with CPAP as well as gold standard sleep studies? 2. Does the new wearable device detect OSA in patients undergoing treatment with CPAP more accurately than the CPAP machine can itself. Participants will be asked to wear the following two devices while using their CPAP machine for 2 nights: 1. AcuPebble SA100 (the new wearable device). This device is the size of a 2-pence coin and sits on the front of the neck and attaches via some double sided sticky tape. It is connected via bluetooth to a mobile phone application (app). 2. A multi-channel sleep study, which is the gold standard way of performing sleep studies. Researchers will then compare how much OSA is left in participants, comparing the values from the new device, gold standard sleep study and the CPAP machine itself.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
United Kingdom
Academic Respiratory Department Royal Free Hospital NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Swapna Mandal, PhD
swapnamandal@nhs.net
0207 794 0500
Backup
R&D Manager
rf.randd@nhs.net
02077940500
Time Frame
Start Date: 2022-10-07
Estimated Completion Date: 2024-02
Participants
Target number of participants: 25
Related Therapeutic Areas
Sponsors
Leads: Royal Free Hospital NHS Foundation Trust
Collaborators: Acurable Ltd.

This content was sourced from clinicaltrials.gov