A Study to Evaluate the Effectiveness of Combination of Soft Palate Lift Appliance and Nabho Mudra in the Management of Obstructive Sleep Apnea
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improved effect in the management of obstructive sleep apnea using combination of soft palate lift appliance and Nabho Mudra
研究概览
简要总结
Obstructive Sleep Apnea is a disorder characterized by repeated episodes of partial or complete obstruction of the upper airways. A flaccid, low-draped soft palate leads to vibration of uvula, causes snoring and as further complication, soft palate collapses and blocks the airways during sleep.
Clinical manifestations of OSA are recurrent apnea (the severity of OSA is determined by Apnea-Hypopnea Index (AHI) – 5.0 – 14.9 events/h in mild OSA, 15 – 30 events/h in moderate OSA and > 30 events/h in severe OSA), hypoxia, increased negative intrathoracic pressure causing impaired CNS, CVS and metabolic function.
Soft Palate Lift Appliance displaces soft palate superiorly and its regular usage leads to stiffening of soft palate musculature and enhance the airway passage by increasing the upper pharyngeal dimensions.
Yoga is an earliest Indian physical, mental and spiritual practice.Various Asnas and Mudras are used as Therapeutic practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Snoring Excessive daytime sleepiness Witnessed breathing interruptions Increased neck circumference Soft palate elongation Macroglossia Tonsillar enlargement Nocturia Morning headache.
排除标准
- •Systemic diseases and hospitalization Hypersensitive Gag Reflex Morphologic abnormalities such as Retrognathia , Pierre-Robin syndrome History of Drug and Alcohol addiction.
结局指标
主要结局
Improved effect in the management of obstructive sleep apnea using combination of soft palate lift appliance and Nabho Mudra
时间窗: 6 months
次要结局
- Improved effect in the management of obstructive sleep apnea using soft palate lift appliance & Nabho Mudra individually.(1 year)
研究者
KEVIN REJI K
KANNUR DENTAL COLLEGE