Monitoring OSA patients on CPAP with a wearable device
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)
Royal Free Hospital NHS Foundation Trust · NCT06097949
This study is testing a new wearable device to see if it can better detect sleep apnea in patients who are already using a CPAP machine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Royal Free Hospital NHS Foundation Trust (other) |
| Locations | 1 site (London) |
| Trial ID | NCT06097949 on ClinicalTrials.gov |
What this trial studies
This observational trial aims to evaluate the effectiveness of a new wearable device, AcuPebble SA100, in detecting ongoing obstructive sleep apnea (OSA) in patients who are already undergoing CPAP therapy. Participants will wear the device alongside a multi-channel sleep study for two nights to compare its detection capabilities against traditional sleep studies and the CPAP machine itself. The study seeks to address the challenges of accurately monitoring residual OSA events and improving patient outcomes through better adherence to therapy.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with moderate to severe OSA who have been compliant with CPAP therapy for over three months.
Not a fit: Patients under 18, those with communication barriers, or individuals with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the monitoring of OSA in patients using CPAP, leading to improved treatment adherence and better health outcomes.
How similar studies have performed: While the approach of using wearable technology for monitoring OSA is gaining traction, this specific device's effectiveness compared to traditional methods is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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 2. Patients who have been established on CPAP therapy for \> 3months 3. Patients who are deemed compliant on CPAP therapy (average use ≥ 4 hours/night for ≥ 70% of the last 28 days) Exclusion Criteria: * 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)
Where this trial is running
London
- Academic Respiratory Department Royal Free Hospital NHS Foundation Trust — London, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Swapna Mandal, PhD
- Email: swapnamandal@nhs.net
- Phone: 0207 794 0500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sleep Apnea, Obstructive, OSA, CPAP, Wearable technology