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
- 60
- 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. Children with Down syndrome and Prader-Willi syndrome have many predisposing factors for OSA, including mouth breathing, narrow upper airways resulting from craniofacial abnormalities, and generalized hypotonia, which increases UA collapsibility and multilevel obstructions. Adenotonsillectomy is the first-line treatment. Unfortunately, up to 55% of children with Down syndrome and up to 79% of children with Prader-Willi syndrome suffer from residual OSA after adenotonsillectomy. Therefore, exploring other treatment options for these children 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 Down syndrome or Prader-Willi syndrome and obstructive sleep apnea. 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 20 weeks of orofacial myofunctional therapy on oromyofunctional, sleep and sleep-related quality of life outcomes in children with OSA (AHI > 1) and Down syndrome or Prader-Willi syndrome.
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
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 4-18
- •Diagnosed with Down syndrome or Prader-Willi syndrome
- •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 (not related to Down syndrome or Prader-Willi syndrome)
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 20 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 20 weeks of therapy))
- Orofacial strength(measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy))
- Sleep: PSG(measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy))
- Quality of Life outcomes: CHQ-PF28(measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy))
- Sleep: PSQ(measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy))
- Sleep: BSQ(measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy))