Effect of Comprehensive Rehabilitation on Apnea Hypopnea Index in patients with Obstructive Sleep Apnea: A Randomized Controlled Trial
试验速览
- 阶段
- 1/2 期
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- 1. Apnea Hypopnea Index
研究概览
简要总结
“Obstructive sleep apnea (OSA) is a breathing disorder which is sleep related, marked by episodes of decreased and complete stoppage of ventilation (hypopnea and apnea)â€. It is characterized by recurrent obstruction of upper airway in sleep leading to oxyhaemoglobin desaturation and arousals from deep sleep. According to recent study reports, it was found that approximately 936 million adults of age 30 to 69 years suffer from mild to moderate OSA worldwide. In India, the prevalence of OSA was 52 million as of 2021. OSA risk increases with the age. Also, males are more commonly affected.
OSA patients present with arousals from sleep at night, which are characterized by collapse of oropharyngeal airway. It results in excessive daytime sleepiness. Moreover, loud and bothersome snoring, choking and gasping during sleep are reported by the bed partners of these individual. This is accompanied by a change in breathing pattern. There is predominant thoracic breathing with a greater paradoxical motion of the abdomen. Moreover, patients with OSA tend to do oral and oro-nasal breathing in sleep.
The episodes of hypopnea and apnea during sleep are measured by polysomnography or home sleep testing with Apnea Hypopnea Index (AHI) being a vital measure of the test for OSA patients. Pharmacological management of OSA is not approved. However,S.G. Schütz et al. concluded in the systematic review that, pharmacological treatment can be used as an adjunct therapy as it has only mild to moderate effect on OSA severity. Besides, these medications have potential negative effects. Hence, the non-pharmacological management involving continuous positive airway pressure (CPAP) is considered as the first line of treatment. Evidences have showed the effectiveness of CPAP in decreasing the severity of OSA and improving sleep quality. However, there are side effects of CPAP which results in decreased adherence of patients to the treatment.
Myofunctional therapy serves as an adjuvant treatment for OSA patients. It involves isotonic and isometric oropharyngeal exercises, targeting the tongue and pharyngeal musculature. A recent systematic review by Rueda JR et al has established the positive effects of myofunctional therapy in OSA patients. In another study, R. Courtney et al. showed the effectiveness of functional nasal breathing rehabilitation technique on patients with nasal obstruction and self reported mouth breathing. It stated that these patients reported decreased mouth breathing, reduced snoring and improved sleep. Therefore further studies are needed on this technique in patients with impaired sleep.
Comprehensive rehabilitation for OSA focuses on modification of oral and oronasal breathing, improving oropharyngeal muscles and correcting paradoxical breathing pattern. It rehabilitates the patient through functional nasal breathing techniques, isotonic and isometric oropharyngeal exercises and diaphragmatic breathing technique.
To date, literatures have reported on usefulness of CPAP and myofunctional therapy as treatment approaches for OSA patients. Thus, a randomized controlled trial can be done to see the effectiveness of comprehensive rehabilitation for OSA. The primary objectives of the study are to determine the effect of comprehensive rehabilitation on AHI and excessive day time sleepiness. The secondary objectives are to determine its effect on oxygen desaturation, snoring, sleep quality and on the components of breathing dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients diagnosed with mild and moderate OSA (with AHI ≥5 to ≤ 30) 2.BMI less than 40 kg/m2.
排除标准
- •1.Patients with obstructive nasal disease such as allergic rhinitis.
- •2.Individuals with craniofacial malformations.
- •3.Patients diagnosed with comorbid sleep disorders such as insomnia, restless leg syndrome.
- •4.Pregnant women 5.Patients with history of pharyngeal surgery.
- •6.Patients with history of congestive heart failure, cardiomyopathy, chronic obstructive pulmonary disease, liver cirrhosis.
- •8.Patients with history of stroke.
- •9.Patients with psychiatric illness such as schizophrenia, anxiety disorder, obsessive compulsive disorder, bipolar disorder, attention deficit disorder and hyperactivity disorder.
- •10.Consumption of alcoholic beverages regularly.
- •11.Periodontal disease (gingivitis) 12.Temporomandibular Joint dysfunction.
结局指标
主要结局
1. Apnea Hypopnea Index
时间窗: 1. At baseline (0 weeks), End of the treatment (12 weeks) | 2. At baseline (0 weeks), End of the treatment (12 weeks), Follow up (24 weeks)
2. Epworth Sleepiness Scale
时间窗: 1. At baseline (0 weeks), End of the treatment (12 weeks) | 2. At baseline (0 weeks), End of the treatment (12 weeks), Follow up (24 weeks)
次要结局
- 1. Oxygen Desaturation Index(2. Snoring Index)
