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Идёт набор NCT03924817

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

Наблюдательное Obstructive Sleep Apnea

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Obstructive Sleep Apnea. Базовые параметры: 18 лет — 99 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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).

Подробное описание

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.

Первичные конечные точки

  • Changes of the Apnoea-Hypopnea-Index (AHI) at baseline compared to a follow-up after 3 months [Срок оценки: 3 months]
Вторичные конечные точки (10)
  • Changes in sleep-related quality of life from baseline compared to 3 months follow-up [Срок оценки: 3 months]
  • Changes in daytime sleepiness from baseline compared to 3 months follow-up [Срок оценки: 3 months]
  • Changes in snoring from baseline compared to 3 months follow-up [Срок оценки: 3 months]
  • Usage of the MAD (mandibular advancement device) [Срок оценки: 3 months]
  • Side effects with use of the MAD (mandibular advancement device) [Срок оценки: 3 months]
  • Document comorbidities of enrolled patients [Срок оценки: 3 months]
  • Remuneration of a MAD [Срок оценки: 3 months]
  • Satisfaction with therapy [Срок оценки: 3 months]
  • Document sleep disorders of enrolled patients [Срок оценки: 3 months]
  • Continuation of therapy [Срок оценки: 3 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 4 центра
  • Schlaf- und Beatmungszentrum Blaubeuren — Blaubeuren Abbey
  • Ruhrlandklinik Essen — Essen
  • Zentrum für Schlafmedizin Dr. Warmuth — Berlin
  • Universitätsklinikum Regensburg - Klinik für Innere Medizin II — Regensburg

Идентификаторы

NCT: NCT03924817 · PATT-OSA_Reg_07082023

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗