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

Recruiting now

Conditions studied: Obstructive Sleep Apnea

In brief

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).

Key facts

Study ID

NCT03924817

Run by

ResMed

People needed

500

Starts

2024-02-01

Expected to finish

2025-06-30

Last updated by the study team

2024-10-29

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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