Strengthening Inspiratory and Oropharyngeal Muscles in Moderate Obstructive Sleep Apnea Hypopnea Syndrome

Обзор

The Obstructive Sleep Apnea hypopnea Syndrome (OSAS), whose prevalence is 4% of the French population, can lead to serious health consequences (risk of road accidents, onset of cardiovascular disease, etc.). OSAS corresponds to a certain number of interruptions (apneas) or reductions (hypopneas) of ventilation during sleep. The weakening of the tone of the inspiratory and oropharyngeal muscles is one of the main causes of upper airways obstruction during the inspiratory phase.

Подробное описание

For patients with moderate OSAS, with few or no symptoms, without associated cardiovascular comorbidities, there is no recommended treatment. Rehabilitate the inspiratory and oropharyngeal muscles through muscle strengthening seems to be an alternative to this problem. Therefore, this study proposes a complete rehabilitation care evaluating the effectiveness of the strengthening of inspiratory and oropharyngeal muscles in subject with moderate OSAS.

Вмешательства

• Другое Inspiratory and Oropharyngeal Muscle Strengthening
  Patients will conduct the training at home, 5 days a week for 3 months. They will perform 2 sets of 30 inspirations against resistance (POWERbreathe® K5 , Powerbreathe International Limited, UK), equal to 70% Maximum Inspiratory Pressure (MIP). Patients will be guided for oropharyngeal exercises. The sessions will be supervised by the investigator every 3 weeks. During sessions with the investigator, sessions recorded in the device will be downloaded to verify compliance. A MIP measurement will

Первичные конечные точки

• Apnea-Hypopnea Index (AHI) [Срок оценки: At 3 months]

Вторичные конечные точки (7)

• Maximum inspiratory pressure measurement (cmH2O) [Срок оценки: At 3 and 9 Months]
• Neck circumference (cm) [Срок оценки: At 3 months]
• Epworth sleepiness score [Срок оценки: At 3 and 9 Months]
• Pittsburgh Sleep quality index [Срок оценки: At 3 and 9 Months]
• Quality of life scale : Short Form 12 (SF12) [Срок оценки: At 3 and 9 Months]
• PICOT fatigue scale [Срок оценки: At 3 and 9 Months]
• AHI (Apnea-Hypopnea Index) [Срок оценки: At 9 months]

Критерии участия

Критерии включения

• Moderate SAHOS (15 ≤ AHI ≤30);
• Body Mass Index (BMI) < 35 ;
• Patient affiliated or entitled to a social security scheme;
• Patient having signed a consent to participate in the study.

Критерии исключения

• Excessive daytime sleepiness: Epworth sleepiness score > 10 ;
• Professional driving and history of accidents related to sleepiness;
• Severe obstructive or restrictive ventilatory disorders of neuromuscular origin authenticated by respiratory function tests;
• Patients undergoing treatment for OSAS or requiring immediate initiation of continuous positive airway pressure (CPAP) or a mandibular advancement orthosis;
• Patients who have stopped CPAP or orthosis treatment in less than one month;
• Patients undergoing cardiorespiratory exercise rehabilitation or starting regular physical training;
• Uncompensated heart failure, thoracic sternotomy surgery < 4 months;
• Marked osteoporosis with history of rib fractures;
• History of spontaneous pneumothorax;
• Severe asthma;

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

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 2 центра

• CHU de Grenoble — Grenoble
• Centre Hospitalier Universitaire — Saint-Etienne

Идентификаторы

NCT: NCT06471751 · 23GI019 · 2024-A00601-46

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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