Upper Airway Reeducation in Moderate Obstructive Sleep Apnea Syndrome
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: Experimental, Sham comparator.
- Кому может быть актуально
- Состояния в реестре: Moderate Obstructive Sleep Apnea Syndrome. Базовые параметры: от 18 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
- Франция
- 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
Specific Upper Airway Reeducation in Moderate Obstructive Sleep Apnea Syndrome: a Randomized Controlled Trial
Обзор
The aim of this study is to evaluate the effectiveness of a specific reeducation performed by speech therapists in moderate obstructive sleep apnea syndrome, as an alternative to the continuous Positive Anyway Pressure (CPAP) and the mandibular advancement device.
Подробное описание
Patients will be recruited in the sleep pathology department, following a sleep consultation and/or a polysomnography. They will be randomized between 2 reeducation groups (specific reeducation or sham reeducation) and will have to perform their respective exercises during 3 months. Only one of the 2 reeducations is expected to be effective. To limit performance and measure bias, patients will not be aware of the content of the reeducation in the other group (participants partially blinded of study hypothesis) and therefore these are not described in detail here. The initial clinical assessment will be repeated at 3 and 6 months, by assessors blinded to the reeducation arm, in order to evaluate the short and medium term effectiveness on the the Apnea-Hypopnea Index (AHI) and other outcomes.
Вмешательства
- Другое Experimental
specific reeducation (not detailed to maintain blinding of participants) - Другое Sham comparator
sham reeducation (not detailed to maintain blinding of participants)
Первичные конечные точки
- Change in apnea-hypopnea index (AHI) [Срок оценки: between 0 and 3 months after randomization]
Вторичные конечные точки (12)
- Change of the Apnea-Hypopnea Index (AHI) [Срок оценки: between 0 and 6 months after randomization]
- Change of the MBLF(Bucco-Linguo-Facial Motor Function) score [Срок оценки: between 0 and 3 months and between 0 and 6 months after randomization]
- Change of the lingual strength [Срок оценки: between 0 and 3 months and between 0 and 6 months after randomization]
- Change of lingual endurance [Срок оценки: between 0 and 3 months and between 0 and 6 months after randomization]
- Change of the size of the genioglossus representation in cm² within the motor cortex [Срок оценки: between 0 and 3 months after randomization]
- Change of quality of life on the SF-36 [Срок оценки: between 0 and 3 months and between 0 and 6 months after randomization]
- Change of sleep quality on the Pittsburgh Sleep Quality Index [Срок оценки: between 0 and 3 months and between 0 and 6 months after randomization]
- Change of daytime drowsiness on the Epworth Drowsiness Scale [Срок оценки: between 0 and 3 months and between 0 and 6 months after randomization]
- Presence of subjective symptoms , each taken independently [Срок оценки: At 3 months and 6 months after randomization]
- Change of the cervical circumference measurement (at the level of the cricoid) [Срок оценки: between 0 and 3 months and between 0 and 6 months after randomization]
- Change of the respiratory sensation sitting at rest [Срок оценки: between 0 and 3 months and between 0 and 6 months after randomization]
- Change of change in respiratory sensation between sitting and full decubitus [Срок оценки: between 0 and 3 months and between 0 and 6 months after randomization]
Критерии участия
Критерии включения
- Male or female, 18 years old minimum
- Diagnosis of moderate OSAS: AHI ≥ 15 events/h and < 30 events/h at PSG M0
- BMI < 35 kg/m2
Критерии исключения
- MoCA < 26 (Montreal Cognitive Assessment)
- Craniofacial malformations
- Regular use of hypnotic medications
- Untreated hypothyroidism
- Stroke history
- Cardiac insufficiency
- Severe uncontrolled coronary heart disease
- Severe obstructive nasal disease
- Patients with indication for CPAP in first intention
- Pregnant or breastfeeding woman
- Current participation in another interventional research in OSA
- No affiliation to a social security system or legal beneficiary (except AME,Aide médicale d'état)
- Absence of free, informed, written consent
- Contraindications for TMS: intracranial metallic implant, pacemaker and/or recent or severe cardiac disease, epilepsy, vascular, traumatic, tumor, infectious or metabolic brain lesions, severe alcoholism
- Protected adult under guardianship or curatorship
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
Франция · 1 центр
- Service des pathologies du sommeil, Pitié-Salpêtrière hospital — Paris
Идентификаторы
NCT: NCT05911971 · APHP210997 · 2021-A02688-33