The Effects of Nasal Airflow on Upper Airway Dilator Muscles During Sleep
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Myoelectricity of genioglossus
研究概览
简要总结
Obstructive sleep apnea (OSA) is an increasingly prevalent disorder characterized by repeated upper airway collapse during sleep, resulting in oxygen desaturation and frequent arousals. The etiology of OSA remains unclear.
Many studies indicates an association between nasal obstruction and apnea. However,the precise nature of this relationship is far from clear and the importance of resistance to nasal airflow in the pathogenesis of airway collapse in OSA patients remains contentious.
In this study, investigators perform 4 different ways to change subjective or objective patency of nasal cavity and observe the effects of the nasal airflow on nocturnal breathing, sleep,and upper airway muscles in OSA patients.
详细描述
- All subjects underwent a standard overnight polysomnogram(PSG), including continuous genioglossal electromyography measurement , electroencephalogram, electrooculogram, electrocardiogram, nasal flow (thermister), respiratory (chest and abdominal) movements,oxy-hemoglobin saturation (pulse oximeter), and body position. Apnea event definitions and clinical classification were determined using the American Academy of Sleep Medicine(AASM) guidelines
- Pharyngeal electrical current sensory threshold was performed to identify the different Pharyngeal function between OSA patients and normal controls
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •OSA patients (apnea/hyponea index >5/h）with chronic nasal congestion
排除标准
- •Upper airway surgery;
- •Current treatment with nasal topical steroids or decongestants;
- •Internal medical diseases or psychiatric disorders that interferd with sleep.
研究组 & 干预措施
Obstructive sleep apnea patients
干预措施: Oxymetazoline Nasal Spray (Drug)
Obstructive sleep apnea patients
干预措施: Menthol Nasal Spray (Drug)
Obstructive sleep apnea patients
干预措施: Normal saline Nasal Spray (Drug)
Obstructive sleep apnea patients
干预措施: Nasal mask with partly blocked (Device)
Healthy controls
干预措施: Oxymetazoline Nasal Spray (Drug)
Healthy controls
干预措施: Menthol Nasal Spray (Drug)
Healthy controls
干预措施: Normal saline Nasal Spray (Drug)
Healthy controls
干预措施: Nasal mask with partly blocked (Device)
结局指标
主要结局
Myoelectricity of genioglossus
时间窗: 2 to 6 month
Participants were treated with 4 different nasal intervention ,including Oxymetazoline Nasal Spray, Normal saline Nasal Spray, Menthol Nasal Spray or Nasal mask with partly blocked when they sleep onset. At the treatment periods, subjects underwent overnight polysomnography with synchronous genioglossus electromyography . Genioglossus (GG) activations under different nasal ventilation conditions were compared.
Apnea-hypopnea Index
时间窗: 2 to 6 month
A randomized, placebo-controlled double blind study on the effects of nasal spray oxymetazoline on sleep architecture, respiratory events, body position and subjective scores in OSA patients. All participants received specific physical examinations, subjective scale assessments and a two-night polysomnography sduty (by randomly applying oxymetazoline for one night and placebo for another.).Data collected after oxymetazoline or placebo treatments were compared. Apnea-hypopnea index(AHI),defined as the sum of apneas and hypopneas per sleep hour, was used as an important indicator for assess the severity of OSA.
The pharyngeal current sensory threshold
时间窗: 2 to 6 month
The pharyngeal current perception threshold test was performed before and after different nasal intervention including Oxymetazoline Nasal Spray, Normal saline Nasal Spray, Menthol Nasal Spray or Nasal mask with partly blocked different nasal cavities. Data collected from OSA patients and healthy controls were compared and analyzed.
次要结局
未报告次要终点