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RECRUITINGOBSERVATIONAL

Registry Study on Prescription, Patient Pathways, Therapy Efficacy and Usage of Mandibular Advancement Devices in Obstructive Sleep Apnea - PATT-OSA Registry

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Locations (4)

Schlaf- und Beatmungszentrum Blaubeuren
Blaubeuren Abbey, Badden-Württemberg, Germany
Ruhrlandklinik Essen
Essen, North Rhine-Westphalia, Germany
Zentrum für Schlafmedizin Dr. Warmuth
Berlin, Germany
Universitätsklinikum Regensburg - Klinik für Innere Medizin II
Regensburg, Germany