NCT00772044已完成4 期
Randomized, Double-blind Study to Compare Safety and Effectiveness of the ProventTM Professional Sleep Apnea Therapy Device to Sham for the Non-invasive Treatment of OSAH
Ventus Medical, Inc.33 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2008年11月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 33
- 主要终点
- Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine)
研究概览
简要总结
Primary Endpoints:
•Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine)
Secondary Endpoints: By polysomnography, reduction in:
- AHI with device on vs. off at 3 months, controlling for sleep position
- Oxygen desaturation index with device on vs. off
- Arousal index with device on vs. off
- Duration of snoring with device on vs. off
- Epworth Sleepiness Scale
Patient acceptance, in terms of:
- Refusal rate at screening
- Discontinuation rate during follow-up
- Daily compliance rate
- Device-related adverse events
- Serious adverse events
详细描述
Please see summary above
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Age > 18 years
- •Diagnosis of OSA
- •AHI > 10 on diagnostic PSG performed within last 3 months
- •Investigator believes that subject can benefit from OSA tx
- •Subject understands and is willing and able to comply with study requirements
排除标准
- •Use of any device that interferes with nasal/oral breathing
- •Persistent blockage of one or both nostrils
- •Any chronic sores or lesions on the inside/outside of the nose
- •Chronic use of nasal decongestants other than nasal steroids
- •Oxygen saturation < 75% for > 10% of the diag. PSG
- •Oxygen saturation < 75% for > 25% of the first 4 hours of the diag. PSG
- •Prior or near-miss motor vehicle accident due to sleepiness (last 12 mo.)
- •Current use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants, or other medications likely to affect neurocognitive function and/or alertness
- •History of allergic reaction to acrylic-based adhesives
- •Current acute upper respiratory inflammation/infection or perforation of the tympanic membrane
- •History of frequent and/or poorly treated severe nasal allergies or sinusitis
- •Narcolepsy, idiopathic hypersomnolence, chronic insomnia, RLS, REM sleep behavior disorder or any other diagnosed or suspected sleep disorder
- •Current use of diurnal or nocturnal supplemental oxygen
- •History of CPAP use in the home for OSA tx
- •History of use of oral appliances for OSA tx
- •History of prior surgery for OSA
- •Currently working night or rotating shifts
- •Consumption of > 10 caffeinated beverages per day
- •History of severe cardiovasc. disease, including NYHA Class III or IV heart failure, CAD with angina or MI/stroke in past 6 months
- •History of cardiac rhythm disturbance
- •Uncontrolled hypertension (SBP > 180 or DBP > 105 mm Hg)
- •Uncontrolled hypotension(SBP < 80 or DBP < 55 mm Hg
- •History of severe respiratory disorders or unstable respiratory disease
- •Any other serious, uncontrolled medical condition
- •Females of child bearing age who are pregnant or intending to become pregnant
- •Consumes more than 3 drinks of alcohol/day
- •Chronic neurologic disorders
- •Cancer, unless in remission for more than 1 year
- •Current psychiatric illness
- •Smokers whose habit interferes with the overnight PSG
- •Any known illicit drug usage
结局指标
主要结局
Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine)
时间窗: 3 months
次要结局
- Reduction in AHI, Oxygen desat index, Arousal index & Duration of snoring w/ device on/off;ESS,Patient acceptance,Device-related AEs & SAEs(3 months)
研究者
研究点 (33)
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