NCT01203956已完成不适用
A Multi Center, Prospective, Randomized, Double Blind, Crossover Study to Compare the DeVilbiss AutoAdjust With and Without the Smartflex Device Modification; "AutoAdjust With SmartFlex Study"
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Apnea-hypopnea Index (AHI)
研究概览
简要总结
There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when using the DeVilbiss AutoAdjust device.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Epworth Sleepiness Scale >10
- •Body Mass Index > 26
- •Apnea-hypopnea index (AHI) ≥15 (mod to severe range)
- •AHI ≤ 10 at therapeutic continuous positive airway pressure (CPAP) pressure
- •CPAP naïve patients
- •Polysomnogram (PSG) within 3 months of enrollment
- •Average oxygen saturation by pulse oximetry (SpO2) > 90% during titration
- •Sleep efficiency on titration night ≥ 78%
排除标准
- •Diagnosis of mild obstructive sleep apnea (OSA)
- •Co-morbid conditions which render participation to be at risk these may include patients with congestive heart failure, chronic obstructive pulmonary disease (COPD) or psychiatric illness
- •Allergies to mask materials
- •Difficulties with nasal breathing
- •Evidence of another primary sleep disorder
- •Evidence of arousing periodic limb movements during titration
- •Contraindications as listed on product labeling.
- •Currently diagnosed with depression if symptomatic
- •Predominately central sleep apnea
- •Deemed medically unsuitable by investigator
- •Evidence of any type of infection or treatment of an infectious condition during the period of research participation
- •Full Face Mask during titration
- •Have a bi-level requirement
- •CPAP pressure >15cmH2O
- •Subjects with tracheotomy
- •Uncontrolled hypertension
- •Require supplemental oxygen
- •Stimulants, major tranquillizers or antipsychotics.
结局指标
主要结局
Apnea-hypopnea Index (AHI)
时间窗: 4 weeks
Number of apnea/hypopnea events per hour, measured by SmartLink component of device.
次要结局
- Key Measures That Will be Used to Evaluate the Intervention(s)(2 weeks)
研究者
研究点 (4)
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