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Набор скоро начнётся NCT07049315

Mandibular Advancement Devices for Reflux in Obstructive Sleep Apnea

Фаза III С лечением Gastroesophageal Reflux Disease

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
В протоколе указаны: Mandibular Advancement Device, Lower Oral Device Without Mandibular Advancement.
Кому может быть актуально
Состояния в реестре: Gastroesophageal Reflux Disease. Базовые параметры: 18 лет — 65 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
Бразилия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effect of Oral Mandibular Advancement Devices on Nocturnal Gastroesophageal Reflux in Adults With Obstructive Sleep Apnea: A Randomized Controlled Trial

Обзор

The purpose of this randomized clinical trial is to learn if a mandibular advancement device (a type of oral appliance) can help reduce nighttime acid reflux in adults with obstructive sleep apnea. The study also aims to understand whether this device can improve sleep quality and quality of life. The main questions the study aims to answer are: * Does using a mandibular advancement device reduce the number and intensity of nighttime reflux episodes? * Does the device improve sleep and daily well-being in people with sleep apnea and reflux? Researchers will compare two types of oral appliances: * A mandibular advancement device, which moves the lower jaw forward during sleep * A lower jaw oral device without advancement, which also aims to help people with sleep apnea but does not reposition the jaw Participants will: Wear the assigned oral device every night for 6 months Visit the clinic for check-ups and adjustments Complete short questionnaires about reflux symptoms, sleep quality, swallowing, diet, and quality of life Have saliva pH measured and X-rays taken before and after using the device This study hopes to find out whether oral devices can be a good option for people who do not tolerate CPAP therapy.

Вмешательства

  • Устройство Mandibular Advancement Device
    A custom-made intraoral appliance designed to reposition the mandible forward during sleep. The device increases the upper airway space by maintaining the lower jaw in a protruded position, aiming to reduce airway collapse and decrease nocturnal gastroesophageal reflux. It is fabricated from heat-cured acrylic based on individual dental impressions and bite registrations taken in a protruded mandibular position.
  • Устройство Lower Oral Device Without Mandibular Advancement
    A lower jaw oral appliance made of heat-cured acrylic, fabricated from standard dental impressions and bite registration in habitual occlusion. This device does not reposition the mandible but provides posterior dental disocclusion. It is also used in patients with obstructive sleep apnea and serves as an active comparator to evaluate the specific impact of mandibular advancement on nocturnal gastroesophageal reflux.

Первичные конечные точки

  • Change in nocturnal gastroesophageal reflux symptoms using the N-GSSIQ questionnaire [Срок оценки: Baseline and 180 days after intervention]
Вторичные конечные точки (4)
  • Change in sleep quality using the Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline and 180 days after intervention]
  • Change in daytime sleepiness using the Epworth Sleepiness Scale (ESS) [Срок оценки: Baseline and 180 days after intervention]
  • Change in salivary pH levels [Срок оценки: Baseline and 180 days after intervention]
  • Change in quality of life using the WHOQOL-BREF questionnaire [Срок оценки: Baseline and 180 days after intervention]

Критерии участия

Критерии включения

  • Adults aged 18 to 65 years
  • Clinical diagnosis of obstructive sleep apnea (OSA) confirmed by polysomnography type I
  • Presence of nocturnal gastroesophageal reflux symptoms
  • Not currently using CPAP therapy
  • Dentate individuals able to wear oral devices
  • Able and willing to comply with the study protocol
  • Provided written informed consent

Критерии исключения

  • Severe OSA (Apnea-Hypopnea Index > 30)
  • Current or recent use of proton pump inhibitors or other anti-reflux medications
  • Neurological or neuromuscular disorders
  • Use of removable dental prostheses (partial or total)
  • Prior surgeries for apnea or reflux
  • Known allergy or intolerance to dental acrylic materials
  • Inability to attend follow-up visits or complete questionnaires

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Бразилия · 1 центр
  • Universidade Tuiuti do Paraná - Centro de Diagnóstico das Alterações Temporomandibulares ( — Curitiba

Идентификаторы

NCT: NCT07049315 · NEC01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗