跳至主要内容
临床试验/NCT01135147
NCT01135147Unknown不适用

Dietary Therapy for Obesity-related Sleep-disordered Breathing in Children

Assaf-Harofeh Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Reduction in apnea hypopnea index (AHI)

研究概览

简要总结

The goal of this research is to study the prevalence of sleep disordered breathing and associated morbidity in obese children and to examine the role of diet and physical activity in the treatment of sleep-disordered breathing in obese children.

详细描述

In a prospective cohort study, obese children will be recruited. After informed consent is obtained, all children will complete a standardized sleep questionnaire and a pediatric daily sleepiness scale questionnaire. All participants will undergo a complete physical examination, blood tests for lipid profile, liver enzymes, and Glucose and insulin will be obtained, and liver sonography will be performed to assess for the presence of fatty liver. Nasopharyngeal radiographs will be used to assess adenoidal size based on the method by Cohen and Konak. A standard in-laboratory, overnight polysomnography will be performed, within 2 weeks of enrollment to the study, in the sleep laboratory at Asaf Harofeh Medical Center. Children with severe obstructive sleep apnea, defined as apnea hypopnea index (AHI) > 15 will undergo adenotonsillectomy. All children will be referred for a dietary and physical education program. The first visit with the dietician will be considered day 1 of the study. Children will than be followed monthly by a dietician. After three months of follow-up, subjects will be divided into two groups. Group 1 will include all children who had AHI > 2 on the initial polysomnography (including children who underwent adenotonsillectomy for AHI > 15), and group 2 will consist of children who had AHI < 2 on the initial PSG. Children of group 2 will continue monthly dietary visits as before. Children from group 1 will undergo a second evaluation including questionnaires, laboratory blood tests, liver sonography, nasopharyngeal radiographs, and polysomnography. Children who demonstrate reduction in the AHI based on PSG will be offered to continue with dietary treatment alone. Children with no change in the AHI based on PSG will be offered to undergo adenotonsillectomy in addition to continued dietary management. All children will be followed for a total duration of six months. After six months, all children will be re-evaluated by questionnaires, blood tests, liver sonography, and nasopharyngeal radiographs. Polysomnography will be performed in all children who had an AHI > 2 on the second PSG.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • BMI at or above the 90th percentile

排除标准

  • children with chronic lung or liver disease, mental retardation, syndromes (i.e. prader willi syndrome), endocrine abnormalities (hypothyroidism cushing), chronic medical treatment with oral steroids, or with anti-psychiatric or anti-convulsive medications

结局指标

主要结局

Reduction in apnea hypopnea index (AHI)

时间窗: 3, 6 months

Repeat polysomnography to assess change in AHI following treatment

次要结局

  • Change in subjective complaints and sleepiness(6 months)
  • Change in lipid profile and liver enzymes(6 months)

研究者

申办方类型
Other Gov

研究点 (2)

Loading locations...

相似试验

Obesity and Obstructive Sleep Apnea (OSA) in Children | 临床试验