Registry Study on Prescription, Patient Pathways, Therapy Efficacy and Usage of Mandibular Advancement Devices in Obstructive Sleep Apnea - PATT-OSA Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Changes of the Apnoea-Hypopnea-Index (AHI) at baseline compared to a follow-up after 3 months [Time frame: 3 months]
Secondary outcome measures (10)
- Changes in sleep-related quality of life from baseline compared to 3 months follow-up [Time frame: 3 months]
- Changes in daytime sleepiness from baseline compared to 3 months follow-up [Time frame: 3 months]
- Changes in snoring from baseline compared to 3 months follow-up [Time frame: 3 months]
- Usage of the MAD (mandibular advancement device) [Time frame: 3 months]
- Side effects with use of the MAD (mandibular advancement device) [Time frame: 3 months]
- Document comorbidities of enrolled patients [Time frame: 3 months]
- Remuneration of a MAD [Time frame: 3 months]
- Satisfaction with therapy [Time frame: 3 months]
- Document sleep disorders of enrolled patients [Time frame: 3 months]
- Continuation of therapy [Time frame: 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 4 centers
- Schlaf- und Beatmungszentrum Blaubeuren — Blaubeuren Abbey
- Ruhrlandklinik Essen — Essen
- Zentrum für Schlafmedizin Dr. Warmuth — Berlin
- Universitätsklinikum Regensburg - Klinik für Innere Medizin II — Regensburg
Identifiers
NCT: NCT03924817 · PATT-OSA_Reg_07082023