Effects of Rehabilitation for Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Apnea-hypopea-index
研究概览
简要总结
In previous review study, it was hypothesized that a comprehensive rehabilitation can combine both local pharyngeal muscle exercise and systemic cardiopulmonary rehabilitation for the OSA patients with oropharyngeal muscle dysfunction or ventilator drive instability. To develop a comprehensive rehabilitation model is of innovative care strategy in this study.
详细描述
BACKGROUND: Obstructive sleep apnea (OSA) is a prevalent sleep-related breathing disorder, which was characterized by repetitive events of complete and partial obstructions of the upper airway. The pathogenesis of OSA is interacted by multiple factors, primarily including upper airway (UA) anatomic impairment, ventilatory drive instability, and oropharyngeal muscle dysfunction. However, studies have proven prior oropharyngeal exercise was designed for those OSA patients with oropharyngeal muscle dysfunction. Unlike prior oropharyngeal exercise, comprehensive rehabilitation should emphasize the cardiorespiratory regulation capability in addition to oropharyngeal function.
OBJECTIVES: Therefore, the purpose of this study is to explore both the clinical and biological effects of our comprehensive rehabilitation, we used PSG data as clinical effect and biomarker of inflammation expression as biological effect.
METHODS: Thirty subjects with moderate or severe OSA (AHI≥15) were randomized into intervention group (N=15) and control group (N=15). In intervention group, a 12-week-intervention of out-patient rehabilitation program included oropharyngeal muscle training, threshold respiratory muscle training, and therapeutic exercise.
ANTICIPATED OUTCOMES: The preliminary results would demonstrate promisingly clinical effects and biological effects of our comprehensive rehabilitation model. Therefore, the further studies should emphasize the methods to differentiate diagnosis for the indicated patients with oropharyngeal muscle dysfunction or ventilatory drive instability.
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
- Double (Participant, Outcomes Assessor)
盲法说明
participants and assessors blinded
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 35-65 with or without surgery had difficulty accepting or adhering CPAP
排除标准
- •Smoking or alcoholism
- •Severe allergic rhinitis
- •Stroke history
- •Severe restricted or obstructive pulmonary disease
- •Hypothyroidism
- •DM or HTN without stable control
- •Psychiatric disease
- •Co-existing non-respiratory sleep disorders
研究组 & 干预措施
intervention group
We conducted a twice a week, 12-week-intervention of 'comprehensive rehabilitation'
干预措施: comprehensive rehabilitation (Behavioral)
control group
We kept the patients for the waiting list until after completing baseline and 12-week measurement
结局指标
主要结局
Apnea-hypopea-index
时间窗: Change from Baseline Apnea-hypopnea-index at 12 weeks
average apnea and hypopnea events per hour during sleep test
potential biomarkers of endothelial dysfunction
时间窗: at 12 weeks
count of ICAM-1, VCAM-1, and NF-κB molecule in plasma serum (%)
次要结局
- Hear rate variability(at 12 weeks)
- Oropharyngeal muscle function(at 12 weeks)
- Respiratory muscle function(at 12 weeks)
研究者
Ching-Hsia Hung
Department chairman of physical therapy, College of Medicine, National Cheng Kung University
National Cheng-Kung University Hospital