The Efficacy of the 4-channel Sequential NMES for the Treatment of Sleep Apnea, Single-center Prospective, Open Level, Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- The difference value of polysomnography before and after treatment
研究概览
简要总结
In the treatment of obstructive sleep apnea, by using sequential 4-channel electrical stimulation treatment, unlike conventional positive pressure devices, it can be done more effectively by improving the strength of the biceps and soft palate, which are the causes of sleep apnea. thought.
详细描述
Design: Prospective study Inclusion criteria of patient group: Patients aged 19 to 60 years diagnosed with moderate to severe obstructive sleep apnea(n=11) Main outcome measures: AHI (apnea-hypoapnea index), Oxygen saturation lowering variables (minimum oxygen saturation, oxygen saturation time less than 90% (%), oxygen desaturation index (ODI) , REM sleep time and ratio of each). Satisfaction with sleep and discomfort of electrical stimulation treatment before and after treatment were evaluated on the Likert scale.
Evaluate the state of health before and after electrical stimulation treatment through EQ-5D-5L.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult males and females between the ages of 19 and 60 who do not fall under the exclusion criteria as study subjects
- •Patients with obstructive sleep apnea syndrome confirmed by polysomnography
- •Those who voluntarily consented to the clinical trial
- •Patients with sleep apnea with moderate or higher apnea hypopnea -
排除标准
- •In case of refusal of inspection
- •Patients who do not agree
- •When instructions cannot be performed due to dementia, mental illness, etc.
- •Patients with sleep apnea due to respiratory failure or cervical spine surgery
- •In case of central nervous system abnormalities such as stroke
- •Pregnant and lactating women
- •Patients who cannot apply the electrical stimulation treatment device due to allergy to electrical stimulation pad (allergic reaction to chemical substances such as silicone, polypropylene, polyethylene, etc.), hypersensitivity reaction, etc.
- •Patients with severe regurgitation during electrical stimulation application
- •Others who have comorbidities (e.g., epilepsy, malignant tumors, severe renal/liver/pulmonary diseases, blood coagulation abnormalities, use of anticoagulants, phlebitis, thermophlebitis, etc.)
- •Those who are judged by other researchers to be unsuitable for this clinical trial (e.g., patients with infectious diseases, those who have inflammation or wounds on the skin at the site of electrical stimulation, and those who believe that electrical stimulation can cause abnormalities in the body regardless of disease) judged person)
- •Those who have been diagnosed with a disease that cannot be stimulated
- •i. In patients with peripheral neuropathy (ex. Guillain-Barré syndrome), the electric stimulator does not induce muscle contraction, so it is ineffective.
- •ii. Patients with congenital myopathy and amyotrophic lateral sclerosis do not receive help because muscle contraction is not induced.
- •Patients with sleep apnea due to pharyngeal muscle weakness or abnormal muscle contraction pattern
- •Persons with pacemakers and other internal electrical stimulators
- •Patients with a history of surgery in the area where the medical device is applied, or in the upper respiratory tract or surrounding area
- •Structural diseases such as 'tonsil hypertrophy' and 'soft palate' that can cause 'obstructive sleep apnea' (examined by physical examination)
结局指标
主要结局
The difference value of polysomnography before and after treatment
时间窗: After 8±2 weeks of treatment at home, it is performed within 2 weeks of the end of treatment.
The index for primary efficacy evaluation is the apnea hypopnea index (AHI) calculated based on polysomnography.
次要结局
- Sleep satisfaction and discomfort(After 8±2 weeks of treatment at home, it is performed within 2 weeks of the end of treatment.)
研究者
Ju Seok Ryu
professor
Seoul National University Hospital