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临床试验/NCT03064321
NCT03064321已完成不适用

Self-Management, Insomnia, and Glucose Control in Adults With Diabetes

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
Average Glucose Control for Last 3 Months Assessed by A!C level

研究概览

简要总结

This study will test the effect of the an insomnia intervention with cognitive behavioral treatment delivered via web compared with an information control group on glucose control and self management behavioral in a sample of persons with type 2 diabetes (T2DM).

详细描述

Recent evidence supports that insomnia is a prevalent problem among persons with type 2 diabetes that may be associated with increased daytime sleepiness and fatigue, increased diabetes-related distress, decreased self-management behavior, and worse glycemic control. The main hypothesis of the current application is that a web-based cognitive behavioral treatment of insomnia (Sleep Health Using the Internet: SHUTi) in persons with T2DM will not only improve their nighttime sleep, but also improve their ability to integrate diabetes education into their daily behavior and positively affect their glucose control compared to a web-based Information Control (IC) group. The aims of this study are to 1) obtain preliminary data to facilitate further hypothesis development and enhance the feasibility of conducting a randomized clinical trial to examine if treatment of insomnia results in participant's being better able to integrate diabetes education into their self-management behavior and result in improved glucose control, 2) explore the associations among changes in insomnia severity, fatigue, daytime sleepiness, sleep quality, A1C (a measure of glucose control over the last three months) and diabetes self-management (DSM) behaviors, 3) explore average pre-intervention to post-intervention changes in insomnia severity, daytime symptoms (fatigue, sleepiness, mood) and DSM behaviors (diet and physical activity) in subjects treated with SHUTi + DSM compared to IC + DSM subjects at 3 months, and 4) explore sleep fragmentation as a potential physiological mechanism linking impaired glucose control (A1C) and sleep in subjects with insomnia and T2DM at baseline and 3 months.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) T2DM with suboptimal glucose control
  • (2) age 18 years or older;
  • (3) willing to be randomized to SHUTi or IC group;
  • (4) able to speak, read, and write in English, and
  • (5) insomnia symptoms with at least one daytime consequence [e.g. impaired mood, poor sleep quality, excessive daytime sleepiness, fatigue].

排除标准

  • Type 1 or gestational diabetes
  • Change in oral medications or > 10% change in insulin in last 3 months
  • Acute medical or psychiatric illness or hospitalization ≤ 3 months (such as angina, stroke, major surgery, major depression or serious psychiatric conditions)
  • AHI (apnea-hypopnea index; apnea [cessation of breathing] or hypopnea [reduction in breathing]) ≥ 10 episodes an hour on overnight sleep study
  • Non-ambulatory
  • Self-reported epilepsy, psychotic or bipolar disorder
  • History of near-miss or auto accident during last 12 months
  • Employed in safety sensitive job (e.g. truck driver or airline pilot)
  • Working nights or rotating shifts
  • Regular use of alerting (e.g., modafinil) medications
  • Consumption of alcohol: Men: > 4 drinks a day or > 14 drinks per week
  • Women: > 3 drinks a day or > 7 drinks per week
  • If using sleep medications, the drug and/or dose changed in the past month
  • Depression
  • Medications for psychotic or bipolar disorders
  • No internet access
  • Pregnant or intend to become pregnant in the next four months (postmenopausal or confirmed not pregnant by a urine pregnancy test)

结局指标

主要结局

Average Glucose Control for Last 3 Months Assessed by A!C level

时间窗: After 12 weeks of either the insomnia intervention or the information control intervention

A1C level

次要结局

  • Sleep Quality(After 12 weeks of either the insomnia intervention or the information control intervention)

研究者

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

Eileen R. Chasens

Associate Professor of Nursing

University of Pittsburgh

研究点 (2)

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