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临床试验/NCT07636525
NCT07636525招募中不适用

Sleep and Adolescent Vaccine Immunogenicity (SAVI) Pilot Study

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2026年7月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
66
试验地点
1

研究概览

简要总结

The main reason for this research study is to understand whether the sleep habits of 11-12 years-olds impact their response to a vaccine. The vaccine is called MCV4. It protects against meningococcal illness, which is rare but can be severe. The American Academy of Pediatrics recommends that the vaccine be given at age 11 or 12. The vaccine has been approved for youth in this age range for over 20 years and is one of the vaccines that primary care doctors typically give around this age. However, nobody has studied how sleep affects children's response to it. This could be important because research on adults suggests that sleep affects the immune system. We want to look at that issue in a younger age range.

Participating families will be asked to have their child keep their regular sleep schedule during the 5-week study, without much variation. During that time, they will wear a special wristwatch at night to track their sleep. Each day they will fill out a short online form. They and a parent/guardian will come to Cincinnati Children's twice. Each visit will last 1 - 1 ½ hours. The first visit will happen at the end of the 1st week. The second is at the end of the 5th week. During visits, they will fill out forms and we will get data from the wristwatch. During the first visit, the participating child would get the vaccine. During the second, they will have a blood test.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Healthy 11-12 years olds who have neither had initial meningococcal vaccination nor known exposure to meningococcal illness.

排除标准

  • Condition or treatment resulting in immunosuppression
  • Prior severe vaccine reaction
  • Symptoms of clinical insomnia or organic sleep disorder
  • Known neurologic condition or intellectual/developmental disability
  • Use of a medication that impacts sleep
  • Average nightly sleep of 8-8.99 hours (between the two groups)
  • Daily intake of >1 coffee or "energy drink" or >2 caffeinated sodas.

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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