Effect of strengthening genioglossal and palatoglossal muscles using a spring based device on obstructive sleep apnea
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- 2.Epworth Sleepiness Scale (ESS)
研究概览
简要总结
A randomized controlled trial would be conducted at department of physiotherapy, Sharda Hospital. Age group will be sorted between 30-60 years both male and female. OSA patients (N=) will be selected and randomized via chit method into two groups. Interventional Session will be held on 3 days per week for 6 weeks. The patients will be selected according to the inclusion and exclusion criteria.
The patients will be educated about the treatment and the procedure they are going to receive and its benefits. An ethical approval and informed consent will be taken.
The two groups will be categorized in which Group A will receive tongue muscle strengthening exercise by using a spring-based device (IPR No-504718 has been granted for the device) in which the strengthening of Genioglossal and Palatoglossal muscles of tongue will be held in different directions (Laterally, Upward and Downward) which can lead to the improvement of sleep apnea severity and also improves overall sleep quality.
At first week the treatment will be started with a minimum resistance and it will increase gradually after a week.
Group B will receive placebo treatment in which they receive an inactive treatment.
The outcome measures will be recorded according to the Apnea hypopnea scale (AHS) and Epworth sleepiness scale (ESS) as pre and post intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Witnessed apnea while sleeping- 14 and above event per hour according to AHI that is moderate to severe.
- •Snoring- Positive or Negative.
- •Fatigue- According to Fatigue Severity Scale if a person scores more than
- •Unrefreshing sleep- A person score 9 and above according to ESS.
- •Overweight.
- •Well conscious and oriented.
排除标准
- •1.Pregnancy.
- •2.Ventilated patient.
- •3.Unconscious and non-oriented.
- •4.Oral Infection.
- •5.Use of CPAP.
- •6.Upper airway surgery.
- •7.Neuromuscular disorder.
- •8.Temporomandibular joint disorder or severe jaw pain.
- •9.Severe Dental issue.
- •10.Buccal mucosa carcinoma.
结局指标
主要结局
2.Epworth Sleepiness Scale (ESS)
时间窗: 3 week and 6 week
1.Apnea Hypopnea Index (AHI)
时间窗: 3 week and 6 week
次要结局
- MMT of Tongue(3 week & 6 week)
研究者
Srishty goyal
Sharda university