Effects of Respiratory Muscle Training on Tongue Muscle Function in Healthy Subjects, a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Tongue elevation strength
研究概览
简要总结
This study aims to investigate the effects of respiratory muscle training on tongue muscle function in healthy subjects. We hypothesize that respiratory muscle training can improve strength and endurance of the tongue muscles.
详细描述
In patient with obstructive sleep apnea, studies have shown that respiratory muscle training improved sleep-related outcomes in patients with obstructive sleep apnea (OSA). On the other hand, a recent study showed that expiratory muscle training improved tongue motor strength in patients with OSA. We hypothesize that respiratory muscle training (either Inspiratory Muscle Training (IMT) or Expiratory Muscle Training (EMT)) may elicit sleep-related improvement in patient with OSA through enhancement on tongue muscle function.
To investigate our hypothesis, we will first address this question in a population of healthy subjects. This study will therefore investigate the effects of respiratory muscle training on tongue muscle function in healthy subjects. The primary hypothesis is that the IMT program with lead to an increase in tongue strength compared to the control group. Other hypothesizes are that EMT, but not sham, will also lead to an increase in tongue strength, compared to the control group.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community ambulant adults between 18 to 65 years old as of testing day; able to understand French or Dutch (depending on the study's site of inclusion); BMI ≥ 18 and ≤ 30 kg/m².
排除标准
- •Any diagnosed neuromuscular or cardiorespiratory disease; diagnosed psychiatric or psychological disorders which could affect adherence to or comprehension of instructions; diagnosed eating disorders; previous or ongoing head and neck cancer; diagnosed OSA; presenting a high-risk of sleep-disordered breathing indicated by a NoSAS score of 8 or higher 32 or a STOP-Bang score of 3 or higher 33,34; resting heart rate (HR) > 100 beats per minute (bpm) or < 50 bpm; resting systolic blood pressure (SBP) > 140 or < 90 mmHg, diastolic blood pressure (DBP) > 90 or < 50 mmHg; oxygen saturation (SpO2) < 94% at rest on room air. Individuals with abnormal lung function, i.e., forced expiratory volume in 1 second (FEV1) ≤ 80%, forced vital capacity (FVC) ≤ 80%, and FEV1/FVC ≤ 70%, will also be excluded.
结局指标
主要结局
Tongue elevation strength
时间窗: Measured two times: at baseline and after 8 weeks
Tongue elevation strength (peak pressure) will be measured via the Iowa Oral Performance Instrument (IOPI).
次要结局
- Tongue protrustion strength(Measured two times: at baseline and after 8 weeks)
- Tongue elevation endurance(Measured two times: at baseline and after 8 weeks)
- Tongue protrusion endurance(Measured two times: at baseline and after 8 weeks)
- Maximal inspiratory pressure(Measured two times: at baseline and after 8 weeks)
- Maximal expiratory pressure(Measured two times: at baseline and after 8 weeks)
- Snoring intensity(Measured two times: at baseline and after 8 weeks)
- Tongue base thickness(Measured two times: at baseline and after 8 weeks)
- Total sagittal thickness(Measured two times: at baseline and after 8 weeks)
- Lateral pharyngeal wall thickness(Measured two times: at baseline and after 8 weeks)
- Snoring duration(Measured two times: at baseline and after 8 weeks)
研究者
William Poncin
PhD
Université Catholique de Louvain