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临床试验/NCT06318611
NCT06318611已完成不适用

Sleep Patterns and Chronotype Among Children and Adolescents With Type 1 Diabetes Compared to Case-control Peers Without Diabetes

Koç University1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
168
试验地点
1
主要终点
Sleep health composite

研究概览

简要总结

Type 1 diabetes (T1D) is one of the most common chronic childhood diseases. Recent studies have highlighted the strong association between type 1 diabetes and sleep health problems. Sleep problems have been reported to include sleep onset, sleep maintenance, frequent nighttime awakenings, and daytime sleepiness. Studies show that children with T1D sleep significantly less than their peers without diabetes, and that this is associated with poorer glycemic control in type 1 diabetes due to impaired glucose metabolism.

This study aimed to compare sleep health composite dimensions and chronotype in children and adolescents with and without T1D, and to explore the relationship between sleep and glycemic variability in T1D.

The study was designed as a prospective observational case-control study. The estimated sample size is calculated as 168.

The sleep health composite dimensions were measured using actigraphy, sleep diaries, and self- or parental reports. Sleep disturbance will be assessed using the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) Level 2-Sleep Disturbance Scale Short Form, and the Children's Chronotype Questionnaire will be used to determine the chronotype. Sleep/wake patterns were also assessed using sleep diaries. Glycemic variability was assessed using continuous glucose monitoring (CGM) device parameters.

详细描述

Type 1 diabetes (T1D) is one of the most common chronic diseases in childhood. The prevalence of T1D in Turkey is reported to be 0.75%. Recent studies draw attention to the close relationship between type 1 diabetes and sleep problems. It has been suggested that sleep duration is insufficient and sleep quality is impaired in patients with T1D. Sleep problems have been reported to include sleep onset, sleep maintenance, frequent nighttime awakenings, and daytime sleepiness. Conditions such as nocturnal glycemic variability and fear of hypoglycemia specific to patients with T1D, alarms from devices such as continuous glucose monitors and pumps used in diabetes management, anxiety, stress and depressive symptoms associated with diabetes, and treatment that may sometimes last throughout the night are possible factors that adversely affect the sleep health of people with diabetes. Studies show that children with T1D sleep significantly less than their peers without diabetes and that this is associated with poorer glycemic control in type 1 diabetes due to impaired glucose metabolism. The American Diabetes Association (ADA) has emphasized that sleep health should be included in the routine assessment of people with diabetes by 2022.

This study aimed to compare sleep health composite dimensions and chronotype in children and adolescents with and without T1D, and to explore the relationship between sleep and glycemic variability in T1D.

The study was designed as a prospective observational case-control study. The estimated sample size is calculated as 168.

The sleep health composite dimensions were measured using actigraphy, sleep diaries, and self- or parental reports. This composite evaluates various dimensions of sleep, including regularity, satisfaction, alertness, timing, efficiency, and duration. Each dimension is assigned a code of '1' for 'good' and '0' for 'poor.' The sleep health composite is designed so that a higher score indicates better overall sleep health.

Sleep disturbances were assessed using the DSM-5 Level 2-Sleep Disturbance Scale Short Form. The DSM-5 Level 2-Sleep Disorders Scale short form was used to evaluate sleep disturbances. It is an 8-item scale that specifically evaluates sleep disorders in children and adolescents, within the past 7 days. Each item is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often, and 5=always). The total score ranges from 8 to 40 points, with higher scores indicating more severe sleep disturbances. Sleep/wake patterns were also assessed using sleep diaries.

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
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 6 to 18 years
  • Use of continuous glucose monitor system

排除标准

  • Acute medical condition that can impact sleep (diabetic ketoacidosis, cold, influenza)
  • Diagnosed neurodevelopmental or behavioral conditions like autism spectrum disorder or Attention Deficit/Hyperactivity Disorder
  • Diagnosed sleep disorder (Obstructive Sleep Apnea)
  • Current use of medications that can impact sleep (diphenhydramine)

结局指标

主要结局

Sleep health composite

时间窗: Prospective, up to 24 weeks

The sleep health composite dimensions were measured using actigraphy, sleep diaries, and self- or parental reports. This composite evaluates various dimensions of sleep, including regularity, satisfaction, alertness, timing, efficiency, and duration. Sleep disturbances were assessed using the DSM-5 Level 2-Sleep Disturbance Scale Short Form. The DSM-5 Level 2-Sleep Disorders Scale short form was used to evaluate sleep disturbances. It is an 8-item scale that specifically evaluates sleep disorders in children and adolescents within the past 7 days. Each item is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often, and 5=always). The total score ranges from 8 to 40 points, with higher scores indicating more severe sleep disturbances.

Chronotype

时间窗: Prospective, up to 24 weeks

Chronotype was evaluated by the Children's Chronotype Questionnaire. The Childhood Chronotype Questionnaire was used to evaluate the chronotype in children. This 27-item questionnaire was developed for Turkish children in the light of the Munich Chronotype Questionnaire and the Mornings-Evenings Questionnaire. The chronotypes were classified as morning, intermediate and evening types, corresponding scores of ≤23, 24-32 and ≥33. The child form of the Childhood Chronotype Questionnaire was completed by the parent and the adolescent form was completed by the adolescent.

次要结局

  • Glycemic control(Prospective, up to 24 weeks)
  • Glycemic variability(Prospective, up to 24 weeks)

研究者

发起方
Koç University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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