NCT06556693招募中不适用
Janus II: A Feasibility Study to Evaluate Response to Remede Dual Channel System Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Improvement in sleep disordered breathing
研究概览
简要总结
The objectives of this study are to evaluate the feasibility of the remedē® Dual Channel System at implant and overnight sleep studies and to assess chronic safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe sleep disordered breathing
- •Expected to tolerate study procedures
- •No heart failure or medically stable heart failure
排除标准
- •Currently implanted with a neurostimulator to treat sleep disordered breathing without sponsor approval
- •History of severe COPD or pulmonary arterial hypertension
- •Current or previous history of nerve injury or palsy
- •Prior cervical surgeries or radiation treatment to head region
- •Known need for an MRI
- •History of psychosis or severe bipolar disorder
- •Active Infection or sepsis within 30 days of enrollment
- •Currently on kidney dialysis or significantly reduced kidney function
- •Hemoglobin less than 8g/dl
- •Pacemaker dependance
- •New defibrillator or any implantable device or device generator changeout within 30 days prior to study implant or anticipated within the first 12 months
- •Other conditions or anticipated surgical procedure expected to affect ability to complete study procedures
- •Allergy to contrast dye unless can be prophylactically treated
- •Known pregnancy or planning to become pregnant
结局指标
主要结局
Improvement in sleep disordered breathing
时间窗: 12 months post implant
Demonstration of the acute prevention of sleep disordered breathing events during attended sleep study.
Safety through 12 months
时间窗: 12 Months post implant
Serious adverse event related to implant procedure, device, or stimulation
Successful Implantation
时间窗: implant procedure
Successful Implantation of dual channel system
次要结局
未报告次要终点
研究者
研究点 (6)
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