Minimally Invasive Electrical Stimulation Of The Nerve Hypoglossal for the Treatment of Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Apnea-Hypopnea Index (AHI)
研究概览
简要总结
Minimally invasive electrical stimulation of the nerve hypoglossal for the treatment of obstructive sleep apnea.
To demonstrate the correct stimulation of the medial branches of the hypoglossal nerve and tongue protrusion using a minimally invasive implantation technique in patients with OSA.
详细描述
Study title: Minimally invasive electrical stimulation of the nerve hypoglossal for treatment for obstructive sleep apnea.
Study device: Medtronic 8-contact Vectris subcompact or compact electrode.
Study design: This is an initial feasibility study that seeks to determine the safety and effectiveness of a minimally invasive technique to implant a hypoglossal nerve stimulation electrode in patients with obstructive sleep apnea.
Subjects meeting study eligibility criteria will be implanted with a Medtronic 8-contact Vectris subcompact or compact electrode.
In the follow-up visits, quality of life and sleepiness scales (Epworth) will be performed, and on days 4 and 7 a control polysomnography. All results will be compared with the baseline data obtained at the start of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >22 and <75 years
- •Moderate or severe apnea (Apnea-Hypopnea Index, AHI, between 1550 per hour and <25% of central apneas)
- •Failure of continuous positive airway pressure (CPAP) therapy defined as the inability to eliminate obstructive sleep apnea and hypopnea syndrome (OSAHS) corresponding to an AHI greater than 20/h despite the use of CPAP.
- •No tolerance to CPAP:
- •to. Inability to use CPAP (more than 5 nights a week; more than 4 hours a night).
- •b. Unwillingness to use CPAP (for example, a patient returns the CPAP system after trying to use it).
- •Patients willing and able to give their informed consent.
- •Willing and able to have a pacing system temporarily implanted, and use the patient programmer to activate the stimulation.
- •Willing and able to return for all follow-up visits and sleep studies and able to fill out questionnaires.
排除标准
- •Body mass index (BMI) >32 kg/m.
- •Central or mixed apneas > or = 25%.
- •Patients who are pregnant or planning to become pregnant.
- •Presence of a complete collapse at the level of the palate corroborated by drug-induced endoscopy (DISE).
- •Surgical resection or radiation therapy for cancer or congenital malformations of the larynx, tongue, or throat.
- •Significant comorbidities that make the patient unable or inappropriate to participate in the trial.
- •Patients with a history of lack of response to electrical stimulation of the hypoglossal nerve.
- •Patients with the presence of other implantable electrical devices such as:
- •spinal cord stimulator, pacemaker, cochlear implant, peripheral nerve stimulator, etc.
研究组 & 干预措施
Subjects implanted with a Medtronic 8-contact Vectris subcompact or compact electrode.
Subjects meeting study eligibility criteria will be implanted with a Medtronic 8-contact Vectris subcompact or compact electrode.
干预措施: Medtronic 8-contact Vectris subcompact or compact electrode. (Device)
结局指标
主要结局
Apnea-Hypopnea Index (AHI)
时间窗: 6 months
Demonstrate an AHI reduction from baseline of 50% and an AHI less than 20 on follow-up polysomnography
Oxygen Desaturation Index (ODI)
时间窗: 6 months
Demonstrate at least a 25% reduction in the ODI from the initial value.
Security
时间窗: 6 months
The primary safety objective is to assess the incidence of events Adverse events related to the device and the insertion technique
次要结局
未报告次要终点