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

NCT ID: NCT03924817

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-06-30

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).

Detailed Description

During sleep, the muscles in the oropharyngeal space relax, the tongue falls back and the volume of the pharynx decreases. Air cannot pass through as it would in the awake state and thus airflow limitations occur. Diminishing airflow can lead to snoring or to the airways collapsing completely (obstructive sleep apnea, OSA). Patients who suffer from OSA have trouble breathing during sleep and will have a disturbed sleep architecture as repeated airway closure causes wake reactions and arousals. This does not only lead to severe daytime sleepiness with high risk of causing car accidents, for instance, but also affects synaptic activity during sleep and the balance of blood gas levels. These factors can have a aggravating effect on blood pressure and worsen the prognosis for cardiovascular comorbidities. First line therapy for obstructive sleep apnea (OSA) is positive airway pressure (PAP) that keeps the airways open with a pneumatic splint. Positive airway pressure is being applied through a facial mask and some patients cannot tolerate this therapy or refuse it. An alternative treatment approach is by fitting an MAD that the patient wears during sleep. An MAD pushes the lower jar forward and thereby increases the volume of the upper airways, thus preventing them to close. Studies have shown good compliance with MAD therapy and benefits in terms of sleepiness and quality of life. The Narval registry study aims to investigate MAD usage in real life and reasons for non-compliance. The registry aims to record patient characteristics (e.g. comorbidities) and side effects that lead to a termination of therapy, but also how the costs for therapy are split between the patient and public or private health insurance providers and how this affects therapy initiation and usage.

Conditions

Obstructive Sleep Apnea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Schoebel, Prof

Role: PRINCIPAL_INVESTIGATOR

Ruhrlandklinik Essen

Locations

Schlaf- und Beatmungszentrum Blaubeuren

Blaubeuren Abbey, Badden-Württemberg, Germany

Site Status: NOT_YET_RECRUITING

Ruhrlandklinik Essen

Essen, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Zentrum für Schlafmedizin Dr. Warmuth

Berlin, , Germany

Site Status: NOT_YET_RECRUITING

Universitätsklinikum Regensburg - Klinik für Innere Medizin II

Regensburg, , Germany

Site Status: NOT_YET_RECRUITING

Countries

Germany

Central Contacts

Oliver Munt, PhD

Role: CONTACT

oliver.munt@resmed.de

+491629056360

Facility Contacts

Holger Woehrle, MD

Role: primary

HWoehrle@lungenzentrum-ulm.de

+4973449288970

Christoph Schoebel, Prof

Role: primary

christoph.schoebel@rlk.uk-essen.de

+492014334934

Sarah Terjung, MSc

Role: backup

sarah.terjung@rlk.uk-essen.de

+492014334934

Ralf Warmuth, Dr med

Role: primary

studien@schlafdoktor.de

Michael Arzt, Prof

Role: primary

Michael.Arzt@ukr.de

+499419447232

Other Identifiers

PATT-OSA_Reg_07082023

Identifier Type: -

Identifier Source: org_study_id