NCT03924817 Registry Study on Prescription, Patient Pathways, Therapy Efficacy and Usage of Mandibular Advancement Devices in Obstructive Sleep Apnea - PATT-OSA Registry
| NCT ID | NCT03924817 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ResMed |
| Condition | Obstructive Sleep Apnea |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2025-05-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
During sleep, the muscle tonus in the oropharyngeal space is lost, the tongue might fall back andthe volume of the pharynx decreases. Air cannot pass through as it would in the awake state and thus airflow limitations occur. The person asleep might compensate the flow limitation by breathing faster, which causes the soft tissue to vibrate (= snoring). Further narrowing of the airways can lead to obstructive apneas (complete airway collapse and stopping of airflow). First line therapy for obstructive sleep apnea (OSA) is positive airway pressure (PAP) that keeps the airways open with a pneumatic splint. Since PAP involves wearing a facial mask that applies air pressure into the airways, some patients cannot tolerate this therapy. These patients might be candidates for an alternative treatment approach with a mandibular advancement device (MAD).
Eligibility 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