Registry on the use of mandibular advancement devices for obstructive sleep apnea
Registry Study on Prescription, Patient Pathways, Therapy Efficacy and Usage of Mandibular Advancement Devices in Obstructive Sleep Apnea - PATT-OSA Registry
This study looks at how well mandibular advancement devices work for adults with obstructive sleep apnea and why some people might not stick with the treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | ResMed Industry-sponsored |
| Locations | 4 sites (Blaubeuren Abbey, Badden-Württemberg and 3 other locations) |
| Trial ID | NCT03924817 on ClinicalTrials.gov |
What this trial studies
This registry collects data on the prescription, patient pathways, and efficacy of mandibular advancement devices (MAD) for treating obstructive sleep apnea (OSA). It aims to understand real-life usage and the reasons behind non-compliance with MAD therapy. The study includes patients aged 18 and older who have been prescribed an MAD and can provide informed consent. By analyzing patient experiences and outcomes, the registry seeks to improve treatment approaches for those who cannot tolerate traditional positive airway pressure therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been prescribed a mandibular advancement device for obstructive sleep apnea.
Not a fit: Patients with central sleep apnea, severe dental issues, or insufficient dental health to retain an MAD will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment options for patients with obstructive sleep apnea who struggle with conventional therapies.
How similar studies have performed: Previous studies have shown positive outcomes with mandibular advancement devices, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Prescription of any mandibular advancement device * Age ≥ 18 years * Ability to understand the study information and information on usage of personal data * Signed and dated informed consent Exclusion Criteria: * Patients with central sleep apnea (central AI \> 5/hour) * Patients with loose teeth and severe parodontitis * Patients with completely missing teeth or removable tooth replacement, or with a teeth health insufficient to retain an MAD Patients with missing molars Patients with maximum protrusion of less than 5mm
Where this trial is running
Blaubeuren Abbey, Badden-Württemberg and 3 other locations
- Schlaf- und Beatmungszentrum Blaubeuren — Blaubeuren Abbey, Badden-Württemberg, Germany (Not_yet_recruiting)
- Ruhrlandklinik Essen — Essen, North Rhine-Westphalia, Germany (Recruiting)
- Zentrum für Schlafmedizin Dr. Warmuth — Berlin, Germany (Not_yet_recruiting)
- Universitätsklinikum Regensburg - Klinik für Innere Medizin II — Regensburg, Germany (Not_yet_recruiting)
Study contacts
- Principal investigator: Christoph Schoebel, Prof — Ruhrlandklinik Essen
- Study coordinator: Oliver Munt, PhD
- Email: oliver.munt@resmed.de
- Phone: +491629056360
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.