Oromyofunctional Training: an Innovative Rehabilitation Program for Pediatric Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Sleep: change in OAHI
研究概览
简要总结
Obstructive sleep apnea (OSA) is a prevalent medical condition with important implications for overall health and quality of life in both children. Therefore, it is important to treat OSA early and effectively. However, adenotonsillectomy, the standard therapeutic approach for children with OSA, is often inadequate. Research shows that 20-40% of children still have residual OSA symptoms after surgery. Therefore, exploring other treatment options, specifically for those patients who currently have insufficient therapeutic options, is an interesting and relevant avenue for research.
This study will evaluate the effectiveness of orofacial myofunctional therapy as a treatment option for children with obstructive sleep apnea (OSA). Orofacial myofunctional therapy consists of a set of oropharyngeal exercises to correct abnormal orofacial functions and strengthen upper airway muscles that are involved in maintaining airway patency. Both objective and subjective/patient-reported outcomes are collected to obtain a comprehensive understanding of the potential of orofacial myofunctional therapy as a treatment for OSA.
详细描述
Objective
Determine the effect of 12 weeks of orofacial myofunctional therapy on oromyofunctional, sleep and sleep-related quality of life outcomes in children with OSA (AHI > 1)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 6-12
- •Diagnosed with Obstructive Sleep Apnea on Polysomnography (AHI<1)
排除标准
- •History of Orofacial Myofunctional Therapy
- •Undergoing an orthodontic procedure during the study period
- •Undegoing an OSA treatment during the study period
- •Orofacial congenital deformities
- •Mental retardation (>2 SD above P50)
研究组 & 干预措施
OSA-patients
orofacial myofunctional therapy
干预措施: Orofacial myofunctional therapy (Behavioral)
结局指标
主要结局
Sleep: change in OAHI
时间窗: measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy)
Obstructive apnea hypopnea index measured by polysomnography
次要结局
- Orofacial Myofunctional Outcomes: OMES score(measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy))
- Orofacial strength(measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy))
- Sleep: PSQ(measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy))
- Sleep: BSQ(measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy))
- Quality of Life outcomes: CHQ-PF28(measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy))
- Sleep: PSG(measurement 1: pre therapy, measurement 2: post therapy (after 12 weeks of therapy))