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临床试验/NCT00156442
NCT00156442已完成不适用

OSAS in Children With Cleft Lip/Palate

University of Rochester1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2005年9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
100
试验地点
1

研究概览

简要总结

The study is to examine the relationship between sleep apnea and neurocognitive behaviors in children with cleft lip/palate. Describe the incidence and severity of obstructive sleep apnea in an unselected population of grade school aged children with surgically repaired cleft palate.

A. Is the incidence of OSA higher in children with cleft palate than age matched historical control groups? B. Are nighttime symptoms an adequate screening tool to exclude the diagnosis of OSA in children with surgically repaired cleft palate? Describe the velopharyngeal closure patterns during speech in an unselected population of grade school aged children with surgically repaired cleft palate. Describe the neurobehavioral phenotype of an unselected population of grade school aged children with surgically repaired cleft palate.

详细描述

Obstructive sleep apnea is closely associated with measurable, impaired cognitive function among otherwise neurologically normal, healthy children . In addition, at least one recent study has reported mild hyperactive-impulsive symptoms among children with sleep disordered breathing . Cleft lip and cleft palate comprise the fourth most common birth defect affecting 1 in 700 newborns. Despite surgical repair, nearly one in four children with surgically repaired cleft palate will have significant velopharyngeal dysfunction . Velopharyngeal closure is expected in nearly all sounds in the English language. As a result, incompetence results in significant speech disability. Because hypernasal speech patterns are more functionally disabling than hyponasality, surgeons tend to err on the side of over-closure of the nasopharynx in an effort to improve the intelligibility of a child's speech when performing secondary speech procedures. Thus, surgical speech procedures are well known to result in clinically significant obstructive sleep apnea . Unfortunately, no data exists about the impact of obstructive sleep apnea on neurocognitive function in children with cleft palate raising the possibility that surgical intervention aimed at improving speech may result in neurocognitive disabilities due to obstructive sleep apnea. Furthermore, no data exists to guide surgeons as to the relative impact of poor speech versus sleep apnea on global neurocognitive and academic functioning. We therefore hypothesize that unrecognized obstructive sleep apnea occurs in patients with surgically repaired cleft palate and results in demonstrable neurobehavioral sequelae. In order to address these hypotheses, we propose the following specific aims:

Specific Aim #1:

Describe the incidence and severity of obstructive sleep apnea in an unselected population of grade school aged children with surgically repaired cleft palate.

A. Is the incidence of OSA higher in children with cleft palate than age matched historical control groups? B. Are nighttime symptoms an adequate screening tool to exclude the diagnosis of OSA in children with surgically repaired cleft palate? Detailed measurement of respiratory disturbances during sleep affecting both gas exchange and sleep state continuity will be performed via polysomnography. Comparisons will be made between snoring and non-snoring groups. Additional comparisons will be made with the literature where appropriate. Although sleep disordered breathing is well known to occur with increased frequency in children with craniofacial anomalies, the specific incidence in children with cleft palate remains unknown. Whether snoring proves to be an adequate screening tool in children with cleft palate also remains to be proven. We hypothesize that sleep apnea affecting both gas exchange and sleep state continuity will be identified both in the presence and absence of habitual snoring.

Specific Aim #2:

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

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

入选标准

  • 100 children with cleft lip/palate and signs and symptoms of OSAS, parents who can read and write English

排除标准

  • Parents who cannot read and write English, children with severe neurological compromise

研究者

申办方类型
Other

研究点 (1)

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