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临床试验/NCT02786953
NCT02786953已完成不适用

Sleep Coach: Sleep Promotion to Improve Diabetes Management in Adolescents With T1D

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年10月19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
40
试验地点
2
主要终点
Sleep Quality: Baseline

研究概览

简要总结

Adolescents with type 1 diabetes (T1D) are at increased risk for problems with adherence and suboptimal glycemic control, and novel approaches are needed to improve outcomes in this high-risk population. The majority of adolescents obtain insufficient sleep (defined as <8 hours/night), and sleep disturbance has been significantly associated with poorer adherence and predicted greater problems with quality of life and worse glycemic control. Yet, no interventions have addressed sleep in youth with T1D. Working from a biopsychosocial and contextual model of sleep, the investigators propose to tailor a sleep-promoting intervention to meet the needs of adolescents with T1D by conducting interviews with to identify the barriers and facilitators to adequate sleep specific to this population. The sleep-promoting intervention will be developed and tested, building on successful sleep interventions in other populations, including components such as limiting caffeine, establishing a media curfew, and positive bedtime routines, while addressing the needs unique to adolescents with T1D, such as fear of hypoglycemia. The study will be conducted by a multidisciplinary team, consisting of Sarah Jaser, PhD, a pediatric psychologist, and two co-investigators, Beth Malow, MD, MS, a neurologist with specialty in sleep medicine, and Jill Simmons, MD, a pediatric endocrinologist. Sleep is a potentially modifiable risk factor that may have both a physiological and behavioral impact on diabetes outcomes. Given the strong associations between sleep and diabetes outcomes in the preliminary data, and recent evidence from sleep restriction studies indicating the impact of insufficient sleep on insulin sensitivity, behavior, and mood, there is reason to believe that a sleep-promoting intervention has the potential to improve outcomes in adolescents with T1D indirectly by improving adherence and directly through its effect on metabolic function. Therefore, the proposed study offers a novel approach to improve adherence, quality of life, and glycemic control in adolescents with T1D.

详细描述

Working from a biopsychosocial and contextual model of sleep, this study will pilot test a sleep-promoting intervention tailored to meet the needs of adolescents with T1D, building on successful sleep interventions in other populations, including components such as limiting caffeine, establishing a media curfew, and positive bedtime routines, while addressing the needs unique to adolescents with T1D, such as fear of hypoglycemia. The study will be conducted by a multidisciplinary team, consisting of Sarah Jaser, PhD, a pediatric psychologist, and two co-investigators, Beth Malow, MD, MS, a neurologist with specialty in sleep medicine, and Jill Simmons, MD, a pediatric endocrinologist. Sleep is a potentially modifiable risk factor that may have both a physiological and behavioral impact on diabetes outcomes. Given the strong associations between sleep and diabetes outcomes in the preliminary data, and recent evidence from sleep restriction studies indicating the impact of insufficient sleep on insulin sensitivity, behavior, and mood, there is reason to believe that a sleep-promoting intervention has the potential to improve outcomes in adolescents with T1D indirectly by improving adherence and directly through its effect on metabolic function. Therefore, the proposed study offers a novel approach to improve adherence, quality of life, and glycemic control in adolescents with T1D.

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
Single (Investigator)

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with type 1 diabetes for at least 12 months
  • Speak and read English
  • Report Insufficient sleep (< 8 hours/night most school nights)

排除标准

  • Other major health problems or sleep disorders (other than insomnia)

结局指标

主要结局

Sleep Quality: Baseline

时间窗: baseline

Sleep quality will be measured with the Pittsburgh Sleep Quality Index total score. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.

Sleep Quality 3 Months

时间窗: 3 months

Sleep quality will be measured with the Pittsburgh Sleep Quality Index total score. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.

Glycemic Control (HbA1c) 3 or 6 Months

时间窗: 3 months or 6 months

HbA1C is a measure of average blood glucose levels. It is measured quarterly at regular clinic visits.

Sleep Duration: 3 Months

时间窗: 3 months

Sleep duration will be measured with actigraphy (total sleep time)

Sleep Duration: Baseline

时间窗: baseline

Sleep duration will be measured with actigraphy (total sleep time)

Glycemic Control (HbA1c) Baseline

时间窗: Baseline

HbA1C is a measure of average blood glucose levels. It is measured quarterly at regular clinic visits.

次要结局

  • Quality of Life (PedsQL)(Baseline and 3 months)
  • Adherence (Self Care Inventory) Parent(Baseline and 3 months)
  • Adherence (Self Care Inventory) Teen(Baseline and 3 months)

研究者

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

Sarah Jaser

Associate Professor

Vanderbilt University Medical Center

研究点 (2)

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