AcuPebble to Remotely Monitor Patients With OSA on CPAP Therapy

NCT06097949 | Unknown

• 1 other identifier: 311874
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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 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. 1.Does the new wearable device detect OSA in patients undergoing treatment with CPAP as well as gold standard sleep studies?
2. 2.Does the new wearable device detect OSA in patients undergoing treatment with CPAP more accurately than the CPAP machine can itself.
3. 3.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).
4. 4.A multi-channel sleep study, which is the gold standard way of performing sleep studies.

Conditions

Sleep Apnea, Obstructive

Keywords

OSA; CPAP; Wearable technology

Outcome Measures

Primary Outcomes (1)

• Accuracy of the residual AHI measured by AcuPebble SA100

  Our primary outcome will be to measure the residual AHI with AcuPebble SA100 and compare the accuracy of this measurement against a gold standard multi-channel sleep study. The residual AHI is a measurement that quantifies the amount of sleep disordered breathing that is still present despite treatment.

  6 months

Secondary Outcomes (3)

• Comparing the residual AHI measured by AcuPebble SA100 and the CPAP machine

  6 months

• Accuracy of the effective AHI measured by AcuPebble SA100

  6 months

• Measure the acceptability of AcuPebble SA100

  6 months

Interventions

AcuPebble SA100 DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an existing diagnosis of obstructive sleep apnoea who have been established on continuous positive airway pressure (CPAP) therapy and are deemed compliant with therapy.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Royal Free Hospital NHS Foundation Trust: lead
• Acurable Ltd.: collaborator

Study Sites (1)

Academic Respiratory Department Royal Free Hospital NHS Foundation Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Swapna Mandal, PhD

CONTACT

0207 794 0500; swapnamandal@nhs.net

R&D Manager

CONTACT

02077940500; rf.randd@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 24, 2023
• Study Start: October 7, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)