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临床试验/NCT01276860
NCT01276860已完成不适用

The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea

University of Arkansas2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
2
主要终点
Number of Participants Who Achieved Criteria of Obstructive Sleep Apnea in the PVT Assessment

研究概览

简要总结

Obstructive sleep apnea results in decreased attentiveness and response times in patients. The objective of this study is to quantify these consequences in pediatric OSA patients using an already established tool for examining the results of sleep deprivation and fragmentation: psychomotor vigilance testing. PVT has been used in children, but has not been studied in pediatric OSA patients. This study aims to employ PVT along the normal course of diagnosis and treatment of pediatric OSA patients in our clinical practice at Arkansas Children's Hospital. The investigators hypothesize that pediatric OSA patients will exhibit decreased PVT scoring when compared to children without OSA, and that PVT can be used to diagnose and monitor treatment outcomes in these patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy pediatric patients ages 6-18 years old
  • with symptoms of OSA (snoring, pauses in sleep breathing, restless sleep, frequent arousals, excellive daytime sleepiness, morning headaches)
  • with physical exam findings consistent with adenotonsillar hypertrophy
  • those identified as good candidates for adenotonsillectomy
  • who are to undergo a polysomnogram as part of their preoperative work-up

排除标准

  • History of attention deficit disorder, developmental delay, or mental retardation
  • Children taking any neurotropic medications (including antiepileptics, antidepressives, and stimulants)
  • Children previously treated for OSA (surgically or medically)
  • Children with significant comorbidities including other sleep-related disorders

结局指标

主要结局

Number of Participants Who Achieved Criteria of Obstructive Sleep Apnea in the PVT Assessment

时间窗: 10-20 minutes each session, 3 sessions total

Subjects with obstructive sleep apnea will be asked to participate in 3 sessions. Your child will be asked to complete some noninvasive tests at each session. These tests consist of Psychomotor Vigilance Task testing. A Psychomotor Vigilance Task (PVT) will measure your level of alertness and attentiveness. The PVT involves pressing a button after hearing a specific tone or seeing a flashing light. This test takes approximately 10 minutes to complete. The PVT testing will be done at the first clinic visit, then before any treatments, and finally after treatments have taken place. Outcome Measure is full completion of the PVT testing.

次要结局

  • Number of Participants Who Achieved Criteria of No Sleep Complaints in the PVT Assessment(10-20 minute session, 1 session)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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