The Efficacy and Maintain Effect of Oropharyngeal Rehabilitation on Obstructive Sleep Apnea Patients After Palatal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- CT
研究概览
简要总结
The goal of this clinical trial is to evaluate the maintain effect of palatal surgery and oropharyngeal rehabilitation (OPR) by using the severity of obstructive sleep apnea (OSA), tongue muscle strength and the space of the upper airway in patients with OSA.The main questions it aims to answer are:
- Will the severity of OSA, tongue muscle strength and the space of upper airway improve more in the palatal surgery combined OPR group than the other two groups?
- Will The maintain effect of tongue muscle strength and the space of upper airway be better in the palatal surgery combined OPR group? Participants will be divided into 3 groups including palatal surgery combined OPR group, palatal surgery group and OPR group by the doctor's advice and their willingness.The OPR for the treatment groups included three 30-minute sessions of OPR per day, and the exercise would be performed 3-5 days per week for 3 months.
详细描述
Background: The pathophysiology of obstructive sleep apnea (OSA) includes anatomical and non-anatomical factors. The patients who are suitable for sleep surgery may have the non-anatomical factors at the same time. Oropharyngeal rehabilitation (OPR) for the extrinsic and intrinsic muscles of the tongue might mitigate sleep apnea by preventing airway collapse and reducing the volume of the tongue base. In addition, previous studies also suggested that increasing the tension of the tongue extrinsic/intrinsic muscles may decrease the collapsibility of the upper airway and further prevent airway collapse during sleep. Although palatal surgery and OPR both can improve the severity of OSA, there is lack of literatures about the maintain effect of palatal surgery combined OPR. The aim of this study is to evaluate the maintain effect by using the severity of OSA, tongue muscle strength and the space of the upper airway. Our team have developed force sensing resistor to record the times and frequency of OPR at home from 2022. However, the investigators have to use SD card to record data in the present version. The investigators will optimize the force sensing resistor to upload data to Google Drive by using wifi. In this way, the investigators will know the daily training situation and give feedback to participants immediately by using LINE.
Methods：Seventy-five adult OSA patients will be recruited for this study. Participants will be divided into 3 groups including palatal surgery combined OPR group, palatal surgery group and OPR group by the doctor's advice and their willingness. In the palatal surgery combined OPR group, the participants will receive the palatal surgery and 3-month OPR. In the palatal surgery group and OPR group, the participants will receive palatal surgery or 3-month OPR, respectively. The OPR for the treatment groups included three 30-minute sessions of OPR per day, and the exercise would be performed 3-5 days per week for 3 months. The performance of the home exercise will also be recorded by the force-sensing resistor. In addition to home exercise sessions, there will also be twice-weekly clinical visits to adjust the contents of OPR program and monitor training progress. To evaluate the effect of treatments on the severity of OSA, tongue muscle strength and the space of the upper airway, the participants will receive polysomonogrphy test, tongue muscle strength test and computed tomography. The time of evaluation will include baseline, 3 and 6 months after treatment.
Expected outcomes：
- The severity of OSA, tongue muscle strength and the space of upper airway will improve more in the palatal surgery combined OPR group than the other two groups.
- The maintain effect of tongue muscle strength and the space of upper airway is better in the palatal surgery combined OPR group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild to severe obstructive sleep apnea patients
排除标准
- •Chronic rhinosinusitis with nasal polyps
- •Adenoidal hypertrophy
- •Bilateral tonsile hypertrophy
- •Morbid Obesity
- •Drug or alcohol abuse in one year
- •Pregnancy
- •Severe lung disease
- •Heart disease with high risk of exercise
- •Neuromuscular disease that can't follow the exercise program
- •Central or mixed sleep apnea
结局指标
主要结局
CT
时间窗: 10-20 minutes
Each participant will maintain their tongues in the resting position, without swallowing, during CT. Pharyngeal airway volume, minimal cross-sectional areas, minimal distance between the lateral pharyngeal wall on both sides, and minimal distance between the anterior and posterior pharyngeal wall on the tip of the epiglottis will be measured. The detail description of each measurement are in secondary outcome measure. Experienced radiologists will perform image reconstruction and data analysis.
Polysomnography (PSG)
时间窗: Single night (8 hours)
PSG will include electroencephalography, electrooculography, electromyography, thoracic and abdominal respiratory inductance plethysmography, body position sensor-modified lead II electrocardiography, oronasal thermistor, nasal cannula pressure transducer, finger pulse oximetry. The detail descriptions of each measurement are in secondary outcome measure. From the abouve measurements, OSA severity, defined using AHI, will be diagnosed by sleep medicine specialists in the ear, nose, and throat (ENT) department. AHI denotes the number of instances of apnea and hypopnea per hour during sleep. Apnea was defined as a \>90% decrease in airflow and a \>10-s cessation of airflow, and hypopnea was defined as a \>30% decrease in airflow and \>3% decrease in oxygen desaturation or microarousal. AHI of 5 to \<15, 15 to \<30, ≥30 denotes mild, moderate, and severe OSA, respectively.
Tongue muscle strength
时间窗: 10 minutes
Tongue muscle strength will be evaluated on the IOPI system (model 2.2; Northwest, Carnation, WA, USA). The participants will sit in a relaxed position, with their heads parallel to the horizontal plane and their feet on the ground. The evaluation probe will comprise a balloon and plastic catheter. The participants will squeeze the balloon for 3 s at maximum pressure. The maximum pressure of protrusion, lateralization, elevation, and depression will be considered the highest of three measurements, expressed in kilopascals.
Questionnaires (including Epworth Sleepiness Scale, Pittsburgh Sleep Questionnaire Index, Snore Outcomes Survey etc.)
时间窗: 10 minutes
We will use ESS to evaluate daytime sleepiness. We will use PSQI to assess sleep quality and patterns. SOS consists of eight items related to the frequency, duration, severity, and consequences associated with sleep-disordered breathing and specifically snoring. Because of the effect of sleep-disordered breathing on partners, a separate Spouse/Bed Partner Survey (SBPS), comprising three Likert-type items, will also be used.
次要结局
- Minimal cross-sectional areas(10-20 minutes)
- Oronasal thermistor from PSG(Single night (8 hours))
- Electroencephalography from Polysomnography (PSG)(Single night (8 hours))
- Body position sensor-modified lead II electrocardiography from Polysomnography (PSG)(Single night (8 hours))
- Finger pulse oximetry from PSG(Single night (8 hours))
- Pharyngeal airway volume(10-20 minutes)
- Electrooculography from Polysomnography (PSG)(Single night (8 hours))
- Thoracic and abdominal respiratory inductance plethysmography from Polysomnography (PSG)(Single night (8 hours))
- Electromyography from Polysomnography (PSG)(Single night (8 hours))
- Nasal cannula pressure transducer from PSG(Single night (8 hours))
- Minimal distance between the lateral pharyngeal wall on both sides, and minimal distance between the anterior and posterior pharyngeal wall(10-20 minutes)
- Snore Outcomes Survey (SOS)(5 minutes)
- Pittsburgh Sleep Questionnaire Index (PSQI)(5 minutes)
- Epworth Sleepiness Scale (ESS)(5 minutes)
研究者
Yi-Ju, Lai
Institute of Physical Education, Health and Leisure Studies, College of Management, National Cheng Kung University, Tainan, Taiwan
National Cheng Kung University