Myofunctional Therapy in Patients With Mild-moderate Sleep Apnea. Randomized Clinical Trial (MYTOSA).
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in AHI after myofunctional therapy
研究概览
简要总结
The main objective of this study is to compare the change in the apnea-hypopnea index (AHI) in patients with mild to moderate sleep apnea without daytime sleepiness after 12 months of myofunctional therapy exercises with respect to the placebo group (the placebo group will be instructed in simulation exercises that do not alter the function or morphology of the upper airway)
详细描述
Background: Alternative treatment therapies to positive upper airway pressure (CPAP) for obstructive sleep apnea syndrome (OSAS) have been developed in recent years. Myofunctional orofacial therapy (MFT) is one of these alternatives and consists of exercises that improve mobility and increase muscle strength of the orofacial structures that contribute to the etiopathogenesis of OSAS. To date, any study to treat sleep apnea patients under this therapy has been conducted in Spain. Moreover, its long-term effect has not been evaluated worldwide.
Main objective: to compare the reduction in the apnea-hypopnea index (AHI) in patients with mild to moderate sleep apnea without daytime sleepiness after 12 months of myofunctional therapy exercises with respect to the placebo group (the placebo group will be instructed in simulation exercises that do not alter the function or morphology of the upper airway) Methodology: A 12-month, randomized, parallel-group, clinical trial will be conducted. Patients with an AHI ≥ 5 events per hour assessed by a respiratory polygraphy (RP) will be randomized to a MFT treatment branch or to another placebo exercises branch. A speech therapist will instruct patients to perform the exercises in both groups for three months. At the end of this period, a RP will be performed on both groups and the same treatment that they were doing will be maintained at home. One year later, a new RP will be performed and changes in AHI, oximetry parameters and snoring will be compared in both groups, as well as sleepiness, quality of life and the degree of adherence to the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 and under 80 years old.
- •Patients with apnea-hypopnea index from 5 to 29 assessed by a respiratory polygraphy.
- •Absence of daytime sleepiness (Epworth sleepiness scale <12).
排除标准
- •Refractory high blood pressure (blood pressure that is not controlled with three antihypertensive drugs, including a diuretic).
- •Ictus, transient ischemic attack, neuromuscular diseases, acute coronary syndrome or hospitalization for worsening heart failure, in the previous 30 days.
- •Professional drivers, profession of risk or respiratory failure.
- •Previous surgical intervention for the treatment of sleep apnea (those patients who have refused treatment with CPAP or mandibular advancement devices after 1 month of not using them,could be included).
结局指标
主要结局
Change in AHI after myofunctional therapy
时间窗: 3 months;12 months
To compare the apnea-hypopnea index (AHI) in patients with mild to moderate sleep apnea without daytime sleepiness after 12 months of myofunctional therapy exercises with respect to the placebo group.
次要结局
- Change in AIH after 1 year of myofunctional treatment compared to 3 months(3 months;12 months)
- Change in snoring(3 months;12 months)
- Change in oximeter parameters(3 months;12 months)
- Assessment of the degree of therapeutic adherence at 3,6 and 12 months(3 months; 6 months;12 months)
- Assessment of generic health-related quality of life(3 months;12 months)
- Assessment of sleep quality(3 months;12 months)
- Assessment of daytime sleepiness(3 months;12 months)
研究者
Irene Cano-Pumarega
Principal Investigator
Hospital Universitario Ramon y Cajal