NCT03066765已完成不适用
Non-Randomized, Single Arm Study of the New Linguaflex Tongue Retractor for the Treatment of Obstructive Sleep Apnea
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Number of subjects with AHI decrease greater than or equal to 50% and less than a score of 10 according to PSG testing
研究概览
简要总结
Study of tongue implant for treatment of obstructive sleep apnea
详细描述
Subjects with obstructive sleep apnea will be treated with a tongue based suspension implant technique to keep airway open while sleeping. Subjects will be followed a year with primary endpoint of AHI results through Polysomnography readings (PSG) testing in an overnight sleep lab.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age
排除标准
- •Subjects with >20% of their AHI accounted for from central apnea.
- •Mallampanti score of 4
- •Tonsillar hypertrophy (4+)
- •Prior uvulopalatopharyngoplasty (UPPP) procedure
- •Narrowing of hypopharynx airspace more than velopharyngeal airspace as seen on examination or x-ray
- •Tongue thickness <40 mm measured on lateral cephalogram x-ray from the frenulum to linea terminalis
- •More than 10% of sleep time with blood O2 desaturation below 70%
- •Unable and/or unwilling to comply with study requirements
- •Females of child bearing age who are pregnant or intending to become pregnant
- •Allergy to silicone
- •History of radiation therapy to neck or upper respiratory tract
- •Subjects with bleeding disorders, impaired immunity for any reason, or heart attack within the last six months
研究组 & 干预措施
LTR Treatment
Experimental
An implant device (Linguaflex Tongue Retractor) will be placed in the tongue and assessed for safety and efficacy
干预措施: Linguaflex Tongue Retractor (Device)
结局指标
主要结局
Number of subjects with AHI decrease greater than or equal to 50% and less than a score of 10 according to PSG testing
时间窗: 1 year
Recording of Apnea Hypopnea Index through polysomnography during overnight sleep study
次要结局
- Number of subjects with significant change in sleepiness and score of less than 10 using Epworth Sleep Scale(1 year)
- Number of subjects of Adverse Events and Serious Adverse Events through recording number, type and relation to device(1 year)
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