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AcuPebble to Remotely Monitor Patients With OSA on CPAP Therapy

NCT06097949 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2023-10-24

No results posted yet for this study

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.

Conditions

  • Sleep Apnea, Obstructive

Interventions

DEVICE

AcuPebble SA100

This device is not being used as an interventional device but simply a monitoring tool on patients already on CPAP therapy. The device is being used within the scope of it's intended purpose as a medical device to diagnose OSA.

Sponsors & Collaborators

  • Acurable Ltd.

    collaborator INDUSTRY

  • Royal Free Hospital NHS Foundation Trust

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-07
Primary Completion
2024-02-29
Completion
2024-02-29

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06097949 on ClinicalTrials.gov