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Adolescents With Migraine: What's Stress Got To Do With It? (Adostress)

2018年6月6日 更新者：University of Colorado, Denver
The overall objective of this proposal is to better define the relationship between perceived stress, hair cortisol, and migraine in adolescents. This will be done by creating 2 arms of the study: those with migraines (cases) and those without migraines or headaches (controls). Each arm will answer several of the same questionnaires and have hair cortisol samples taken multiple times over the course of 12 weeks.

研究概览

地位

完全的

条件

详细说明

The overall objective of this proposal is to better define the relationship between perceived stress, hair cortisol, and migraine in adolescents. Although adolescents most frequently report stress as their migraine trigger, stress measurement and treatment are usually beyond the scope of routine clinical care. Hair cortisol levels may identify stressed adolescents who need structured stress management, as well as provide objective evidence for the medical community, migraineurs (i.e. individuals who experience migraines), and their families, who may be reluctant to accept stress as a migraine factor. The rationale for this research is that scientific validation of an association between stress and migraine will inform future prevention studies in the headache field and potentially identify a stress biomarker for migraine.

This prospective study will enroll 67 adolescents (aged 13-17) with migraine and 33 adolescents without migraine for 12 weeks with the following aims:

Aim 1: Measure the relationship between hair cortisol concentration and perceived stress in adolescents with and without migraine.

Hypothesis: The association between hair cortisol and perceived stress (3 month averages) will be a positive in both adolescents with and without migraine.

Aim 2: Measure the relationship between migraine frequency with perceived stress and hair cortisol concentration in adolescents with migraine.

Hypothesis: The association between migraine frequency with (a) perceived stress and (b) hair cortisol will be positive in adolescents with migraines.

研究类型

观察性的

注册 (实际的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Colorado
      • Aurora、Colorado、美国、80045
        • Colorado Children's Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

13年 至 17年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

The population to be sampled is adolescents (13-17 years old) with migraines, both male and female. Migraines are common in the pediatric population with a prevalence as high as 10% in children 5-14 years old,1 and 28% in adolescents 15-19 years old (Split W, 1999).

描述

Inclusion criteria:

For Cases:

  • Diagnosis of Migraine as defined by the ICHD-II
  • At least 1 migraine per month

For Controls:

  • No diagnosis of Migraine as defined by ICHD-II
  • No diagnosis of Primary Headache Disorders as defined by ICHD-II

Exclusion Criteria for Migrainers and Non-migrainers:

  • A secondary headache disorder as defined by ICHD-II
  • A continuous headache (i.e. 24 hours a day every day)
  • An underlying neurological condition such as epilepsy, chiari malformation, or neurocutaneous disorder
  • A chronic medical illness including those illnesses that require chronic steroid use such as asthma, cancer or rheumatologic disorders
  • Subject has bleached hair in past 3 months.
  • Pubertal Tanner stage 1 or 2 (Hair cortisol concentration may depend on developmental stage; 59 Tanner staging will be performed by Dr. Kedia).
  • Subject is pregnant or has a positive pregnancy test.
  • Present psychiatric disease as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) (e.g. psychosis, bipolar disorder, major depression, generalized anxiety disorder), alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, or mental retardation) that, in the opinion of the site investigator, would interfere with adherence to study requirements or safe participation in the trial
  • Any and all other diagnoses or conditions which in the opinion of the primary investigator would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the study subject.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Cases
Children with migraines will be placed into this group.
Controls
Children without migraines or headaches will be placed into this group.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Correlation between hair cortisol and perceived stress
大体时间：12 weeks
Hair cortisol (a biomarker of stress) will be correlated with perceived stress (as measured by participant-answered questionnaires). We expect a positive correlation.
12 weeks
Correlation between headache frequency, perceived stress, and hair cortisol.
大体时间：12 weeks
Hair cortisol (a biomarker of stress) will be correlated with perceived stress (as measured by participant-answered questionnaires) and headache frequency (as measured by a headache diary, which will measure how many days per month a child has headaches). We expect a positive correlation.
12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Colorado, Denver

调查人员

  • 首席研究员：Sita Kedia, MD、University of Colorado, Denver

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年9月12日

初级完成 (实际的)

2017年9月15日

研究完成 (实际的)

2017年10月15日

研究注册日期

首次提交

2014年10月3日

首先提交符合 QC 标准的

2014年10月3日

首次发布 (估计)

2014年10月8日

研究记录更新

最后更新发布 (实际的)

2018年6月8日

上次提交的符合 QC 标准的更新

2018年6月6日

最后验证

2018年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 13-3128
  • UL1TR001082 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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