NCT02324790终止不适用
A Multicenter Pilot Study on the Indications of Negative Pressure Sleep Therapy System for the Treatment of Obstructive Sleep Apnea (OSA)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 8
- 主要终点
- Change from baseline of Apnea-Hypopnea Index (AHI)
研究概览
简要总结
This is a pilot study to investigate the efficacy and safety of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.
详细描述
This is an open-lable, single-arm, evaluator-blind and prospective study aimed to evaluate the feasibility of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.
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
盲法说明
evaluator blind
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of OSA, based on AHI 10~60 (as assessed per baseline PSG).
- •Subject understands the study protocol and is willing and able to comply with study requirements and sign the informed consent form.
- •BMI ≦ 28.
排除标准
- •Poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed.
- •Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the device. (e.g. dentures, loose tooth/teeth, temporomandibular joint (TMJ) conditions, or any oral or dental condition that the Investigator believes could be exacerbated by the Sleep Therapy System.
- •History of any OSA surgical treatment including uvulopalatopharyngoplasty surgery (UPPP), maxillomandibular advancement surgery (MMA), radio frequency (RF) ablation treatment, palatal stent devices, etc.
- •History of allergic reaction to silicone.
- •Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than OSA, including insomnia, and central sleep apnea.
- •Currently working nights, rotating night shifts, planned travel across four or more time zones required during study period, or within two weeks prior to study enrollment, or sleep schedule not compatible with sleep lab practices.
- •Current use of medication or other treatment which, in the investigator's opinion, may pose additional risk to the subject or confound the results of the study.
- •Potential sleep apnea complications that, in the opinion of the investigator, may affect the health or safety of the participant, including: low blood oxygen, recent near-miss or prior automobile accident due to sleepiness, reported history of severe cardiovascular disease (including New York Heart Association (NYHA) class III or IV heart failure, CAD with angina or myocardial infarction (MI)/stroke in past 6 months, uncontrolled hypertension or hypotension, cardiac arrhythmias), reported respiratory disorders, or use of medication or other treatment which may pose additional risk to the subject or confound the results of the study.
- •Female subjects who are pregnant or intend to become pregnant during the study period.
研究组 & 干预措施
Treatment
Experimental
Treated with iNAP® Sleep Therapy System on the treatment PSG night.
干预措施: iNAP® Sleep Therapy System (Device)
结局指标
主要结局
Change from baseline of Apnea-Hypopnea Index (AHI)
时间窗: One treatment night
The study was terminated. No enough samples for statistical analysis.
次要结局
- Change from baseline of oxygen desaturation index (ODI)(One treatment night)
- Change from baseline of obstructive apnea reduction(One treatment night)
- Adverse event (AE)/ serious adverse event (SAE) rate and type(From informed consent form obtained to the end of study, average of 4 weeks)
研究者
研究点 (8)
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