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临床试验/NCT01739712
NCT01739712已完成不适用

Students With Diabetes: Does Optimizing Sleep Promote Classroom, Behavioral, and Disease-Related Improvement

University of Arizona1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2012年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
114
试验地点
1
主要终点
Neurocognitive performance

研究概览

简要总结

Sleep intervention for youth with diabetes

详细描述

It is known that sleep disturbances in healthy youth have negative effects on neurobehavioral functioning. Further, data support that individuals with diabetes have more sleep disturbances and compromised neurobehavioral functioning than individuals without diabetes. However, the joint impact of sleep and glucose on neurobehavioral functioning in youth with type 1 diabetes (T1DM) is not yet known. Therefore, our primary study aims are to: (1) determine the relative contributions of various sleep disturbances on glucose control in youth with T1DM; (2) examine the joint impact of glucose control and sleep disturbances on neurobehavioral outcomes in youth with T1DM; and (3) determine if increasing sleep duration relative to youth's typical schedules contributes to changes in glycemic control and neurobehavioral performance. These aims will be achieved by following 120 youth with T1DM ages 10 through 16 for six days of naturalistic sleep using polysomnography, actigraphy, and questionnaires to assess sleep; continuous glucose monitors and hemoglobin A1C values to assess glucose control; and standardized cognitive tasks and behavior rating scales to assess neurobehavioral functioning. Further, the proposed study is innovative in that it will extend existing research by moving from correlational findings to an experimental paradigm by randomizing youth with T1DM to either a Sleep Extension or Fixed Sleep Duration condition for an additional six days. Once our aims are achieved and a causal link is established, the proposed Sleep Extension intervention will advance knowledge about the role of sleep in diabetes management and provide a beneficial intervention to help youth with T1DM.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 16 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •diagnosis of type 1 diabetes
  • •enrolled in school

排除标准

  • •not hospitalized within past month
  • •neurological, developmental, or psychiatric condition that in the opinion of the PI would significantly interfere with sleep or participation

研究组 & 干预措施

Sleep Extension

Experimental

All youth in this condition are asked to extend their sleep to 10 hours or at least one hour, whichever is longer

干预措施: Sleep extension (Behavioral)

Fixed Sleep Duration

Sham Comparator

All youth in this condition are asked to maintain their baseline sleep duration.

干预措施: Fixed Sleep Duration (Behavioral)

结局指标

主要结局

Neurocognitive performance

时间窗: 2 weeks

Cogstate learning and memory tasks

Academic performance

时间窗: 2 weeks

Woodcock Johnson Tests of Achievement-3rd Edition NU and Curriculum-Based Measurements

Academic Rating Scale

时间窗: 2 weeks

A teacher behavioral rating of classroom behaviors and performance

Glucose control

时间窗: 2 weeks

Continuous glucose monitor

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michelle Perfect

Associate Professor

University of Arizona

研究点 (1)

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