Effect of comprehensive rehabilitation on apnea hypopnea index in patients with severe obstructive sleep apnea: a pre-post study
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 42
- 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)”. It is characterized by recurrent obstruction of the upper airway in sleep leading to oxyhaemoglobin desaturation and arousals from deep sleep. In India, the prevalence of OSA was 52 million as of 2021. OSA risk increases with age.
Evidence has shown that CPAP decreases the severity of OSA and improves sleep quality. However, there are side effects of CPAP which results in decreased adherence of patients to the treatment. Comprehensive rehabilitation for OSA focuses on the modification of oral and oronasal breathing, improving oropharyngeal muscles, and correcting paradoxical breathing patterns. It rehabilitates the patient through functional nasal breathing techniques, isotonic and isometric oropharyngeal exercises, and diaphragmatic breathing technique. The primary objectives of the study are to determine the effect of comprehensive rehabilitation on AHI and excessive day time sleepiness among patients with severe OSA. 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
- Na
- 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
- •Patients diagnosed with severe OSA
- •BMI less than 40 kg/m2.
排除标准
- •Patients with obstructive nasal disease such as allergic rhinitis.
- •Individuals with craniofacial malformations.
- •Patients diagnosed with comorbid sleep disorders such as insomnia, restless leg syndrome.
- •Pregnant women
- •Patients with history of congestive heart failure, cardiomyopathy, chronic obstructive pulmonary disease, liver cirrhosis.
- •Patients with history of stroke.
- •Patients with psychiatric illness such as schizophrenia, anxiety disorder, obsessive compulsive disorder, bipolar disorder, attention deficit disorder and hyperactivity disorder.
- •Consumption of alcoholic beverages regularly.
- •Periodontal disease (gingivitis)
- •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
- Oxygen Desaturation Index(At baseline (0 weeks), End of the treatment)
- Snoring Index(At baseline (0 weeks), End of the treatment)
- Pittsburg Sleep Quality Index(At baseline (0 weeks), End of the treatment)
- Manual Assessment of Respiratory Motion(At baseline (0 weeks), End of the treatment)
- Breath Hold Test(At baseline (0 weeks), End of the treatment)
- Self Evaluation of Breathing Questionnaire(At baseline (0 weeks), End of the treatment)
研究者
Mrudula Pawar
Manipal College of Health Professions, Manipal Academy of Higher Education