Neuromodulation Therapy Device for the Treatment of Sleep Apnea
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- We will determine effective device settings on the Neuromodulation Therapy Device (NMTD).
研究概览
简要总结
We are looking to test a novel device in the treatment of Obstructive Sleep Apnea (OSA). Rather than using positive pressure to open the airways, we are testing a device that delivers an auditory tone to affect neuromodulation. We will test its efficacy in treating OSA while minimizing sleep disturbance. As this device is much less cumbersome to wear, we hope this therapy device will also improve compliance with treatment.
详细描述
Neuromodulation Therapy Device for the Treatment of Sleep Apnea
Obstructive sleep apnea (OSA) is a common public health problem with severe health consequences that substantially raises the risk of cardiovascular and cerebrovascular death. Continuous positive airway pressure (CPAP) is currently the most effective treatment option, yet up to half of patients fail to tolerate CPAP and require other approaches. Novel treatments offering alternatives to CPAP are thus sorely needed by those suffering from OSA. The Neuromodulation Therapy Device (NMTD) is a novel potential therapy for OSA. The main goal of our project is to evaluate the efficacy, tolerability, and safety of NMTD in patients with OSA.
Hypothesis 1 - The NMTD device is capable of reducing AHI.
OSA severity is indexed by apnea-hypopnea index (AHI), the number of apnea/hypopnea events occurring hourly during sleep. Our first aim is to determine NMTD's operating characteristics for treatment of OSA. The optimal duration of a detected apnea/hypopnea event before NMTD responds must first be determined. Additional adjustable features include sensitivity of respiratory event sensor, as well as pulse duration, frequency, and intensity of the delivered auditory tone. Since independent adjustment of each of the 4 parameters is not feasible, our screening analysis will test two variables at a time to identify which variables most effectively reduce AHI. This will allow for more practical titration during a therapeutic sleep study and more generalizable application of the device.
Hypothesis 2 - Modified NMTD is as effective and tolerable as CPAP in OSA treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18 years or older
- •Completed a comprehensive Sleep Medicine evaluation and a standard split-night polysomnogram
- •Able to give informed consent
- •Confirmed diagnosis of OSA
- •Positive airway pressure device naive
排除标准
- •Unsuccessful CPAP titration
- •Inability to detect screening tone in either ear without the use of hearing aid
- •Inability to tolerate a 37 dB tone
- •Need for nocturnal oxygen or non-invasive positive pressure ventilation due to hypoventilation/hypercapnia
- •Predominantly mixed or central apneas or those who develop complex sleep apnea during the PSG
- •Neurologic disorders such as seizure disorder or narcolepsy
- •Psychiatric disorders currently not under adequate control
- •Need for nurse or other's assistance during the night due to problems of nocturnal confusion, delirium, or other conditions that would preclude the subject from wearing the device all night
- •Pregnancy (will be tested)
结局指标
主要结局
We will determine effective device settings on the Neuromodulation Therapy Device (NMTD).
时间窗: First year
次要结局
- We will compare the modified NMTD's efficacy and tolerability to that of CPAP in treating OSA.(Second year)