Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- NREM EMGgg
研究概览
简要总结
Sleep Disordered Breathing (SDB) is a spectrum of conditions spanning from Simple Snoring to Severe Sleep apnea. SDB has multiple underlying mechanisms. Some portion of patients have issues with upper airway dilator muscle control; and such patients may be amenable to upper airway muscle training exercises using neuromuscular stimulation techniques. The investigators and others have published on the topic of neuromyopathy in the upper airway, defining a subgroup of OSA patients who may be amenable to training exercises. Based on this background, the investigators seek to test the hypothesis that upper airway tongue muscle training using transoral surface neuromuscular electrical stimulation may have benefits to patients with Simple Snoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmation of snoring: must have a live-in bed partner that reports ≥ 6 months history of habitual snoring (i.e. > 5 days per week)
排除标准
- •AHI > 15/hr
- •BMI > 35
- •Non-English speakers (due to necessity to complete questionnaires)
- •Inability to complete daily neuromuscular stimulation
- •Other sleep disorders
- •Tongue or lip piercing
- •Pacemaker of implanted medical electrical devices
- •Current or recent (within last 6 months) treatment for snoring or sleep apnea
- •Previous oral or pharyngeal surgery other than dental
- •Craniofacial skeletal or muscular abnormalities
- •History of driving or other accidents due to sleepiness or an Epworth score (ESS)> 18
- •Cardiac (other than hypertension), pulmonary, renal, neurologic, neuromuscular or hepatic disease
- •Medications with sedative or myorelaxant properties or effects on cardiac or pulmonary function
- •Substantial alcohol (>3oz/day) or use of illicit drugs
- •Psychiatric disorders (other than depression or anxiety)
- •Snoring less than 20% of total sleep time during baseline polysomnography
结局指标
主要结局
NREM EMGgg
时间窗: 6 hours
Genioglossal muscle activity as measured by two 25 gauge needles each containing a Teflon-coated stainless steel recording wire (\<0.1 mm in diameter with \~1 mm at the tip bared of Teflon and bent to form a small hook) placed perorally 1.5-2 cm into the body of the genioglossus muscle.
Change in percent total sleep time spent snoring
时间窗: 6 hours
Time spent snoring divided by total sleep time as determined by Polysomnogram
次要结局
- Sleep Quality(10 minutes)
- Daytime Sleepiness(10 minutes)
研究者
Robert L. Owens
Associate Physician
University of California, San Diego