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临床试验/NCT06186687
NCT06186687已完成不适用

Rehabilitative Approaches: Myofunctional Therapy and Retropalatal Narrowing and Snoring

Universitas Padjadjaran2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Snoring intensity and frequency

研究概览

简要总结

Sleep is an important activity and snoring is the most often reported complaint. Snoring is also very common in the general population. Moreover, snoring can negatively impact bed companions' quality of sleep, daytime sleepiness, strain of relationships, social embarrassment and disturb mental health that in the end will reduce quality of life. Anatomical risk factors are believed to be one of major contributors to upper airway constriction during sleep. Treatment for this condition include lifestyle modifications (such as quitting alcohol or losing weight), positional therapy, mandibular advancement devices, upper airway surgery, and nasal continuous positive airway pressure. Myofunctional therapy (MT) as an adjunctive or alternative therapy can lower Apnea-Hypopnea Index in obstructive sleep apnea patients with pharyngeal dilator muscle collapse. Although these may be beneficial, the impact of MT on retropalatal narrowing as one of the snoring causes needs to be better established. This study was done to find out the impact of MT in people with snoring who have a collapsed pharynx that is located by a Flexible nasolaryngoscopy.

详细描述

Sleep is an important activity; it makes up one-third of a person's life, and in sleep medicine clinics, snoring is the most often reported complaint. Snoring is also very common in the general population. Studies indicate that women have a higher incidence of this condition above 65 years, increasing after menopause, while men experience it between 45 and 64 years of age. While snoring may be a predictor of the more serious condition of obstructive sleep apnea, primary snoring is common. Moreover, snoring can negatively impact bed companions' quality of sleep, daytime sleepiness, strain of relationships, social embarrassment and disturb mental health that in the end will reduce quality of life. Anatomical risk factors are believed to be one of major contributors to upper airway constriction during sleep. Pharyngeal narrowing can be facilitated by anatomic characteristics such as a large neck circumference, soft tissue, bone, or arteries. Flexible nasolaryngoscopy (FN) is an alternative diagnosis to direct viewing of the airway, from the nasal cavity to the larynx area. Aside from being easier to perform and more affordable, a complete examination of the airway can identify the location of the pharyngeal narrowing that causes obstruction more specifically. Treatment for this condition include lifestyle modifications (such as quitting alcohol or losing weight), positional therapy, mandibular advancement devices, upper airway surgery, and nasal continuous positive airway pressure are among the treatments for treating snoring. Myofunctional therapy (MT) as an adjunctive or alternative therapy can lower Apnea-Hypopnea Index in obstructive sleep apnea patients with pharyngeal dilator muscle collapse. The exercises are non-invasive, cost-effective, and have physiological characteristics. Improvement in upper airway obstruction is supported by improvements in upper airway muscle tone. Although these may be beneficial, the impact of MT on retropalatal narrowing as one of the snoring causes needs to be better established. This study was done to find out the impact of MT in people with snoring who have a collapsed pharynx that is located by a FN.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • high risk of OSA (STOP-Bang questionnaire ≥ 3 and Berlin Questionnaire score positive in ≥ 2 category)
  • Already diagnosed by an Ear, Nose and Throat specialist as having risk of obstructive sleep apnea based on the questionnaire and FN study that showed pharyngeal muscle collapse in the pharyngeal area (velopharyngeal area/retropalatal)

排除标准

  • history of lung disease,
  • craniofacial anatomy abnormalities,
  • consuming drugs with sedative effects, alcohol, anti-depressants, or anti-anxiety groups in the last 3 months before

结局指标

主要结局

Snoring intensity and frequency

时间窗: 6 weeks

Snoring intensity and frequency evaluation were taken from the Berlin questionnaire before and after 6 weeks of myofunctional therapy exercise.

Widening of retropalatal area

时间窗: 6 weeks

The retropalatal area was evaluated with flexible nasolaryngoscopy before and after 6 weeks of myofunctional therapy exercise.

Symptoms of daytime sleepiness

时间窗: 6 weeks

Symptoms of daytime sleepiness was evaluated with Epworth Sleepiness Scale (ESS) score before and after 6 weeks of myofunctional therapy exercise. The minimum values of the socre is 0 and the maximum value is 24. The higher the ESS score, the higher their 'daytime sleepiness', which gives a worse outcome.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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