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临床试验/NCT01570738
NCT01570738已完成不适用

Validation of Home Sleep Testing (WP) Compared to an Overnight Sleep Testing in the Sleep Laboratory

Itamar-Medical, Israel1 个研究点 分布在 1 个国家目标入组 274 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
274
试验地点
1
主要终点
Compare sleep data collected from the Watch-PAT device to PSG data

研究概览

简要总结

Obstructive sleep apnea syndrome (OSAS) is considered to be a major public health problem. The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated. The prevalence of snoring in children is high - 5% in the age group of 6 and less and about 1.5% above. The in-lab sleep study using full Polysomnography (PSG) and the manual scoring criteria set by the American Academy of Sleep Medicine was considered the gold standard for OSAS diagnosis. The high cost of in-lab full night PSG, together with long waiting lists for sleep studies, have led to the commonly used procedure of "split-night" for OSAS patients, as well as to the development of a variety of ambulatory sleep study systems. The primary study objective is to compare the efficacy of the WatchPAT (WP), as an ambulatory device for aiding in the diagnosis of sleep disorders for subjects from age 5 to 90, to the manual scoring of the PSG that serves as a "gold standard".

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
5 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 5-90
  • Subjects that are able to read understand and sign the informed consent form to undergo an overnight sleep study in the clinical sleep laboratory

排除标准

  • Permanent pacemaker.
  • Severe lung disease.
  • Peripheral neuropathy.
  • Finger deformity that precludes adequate sensor appliance.
  • Using one of the following medications: short/Long acting nitrates (less than 3 hours before the sleep study) or alpha-adrenergic receptor blockers (less than 24 hours before the sleep study).

结局指标

主要结局

Compare sleep data collected from the Watch-PAT device to PSG data

时间窗: 3 years

次要结局

未报告次要终点

研究者

发起方
Itamar-Medical, Israel
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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