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临床试验/NCT02964598
NCT02964598Unknown不适用

Sleep Helsinki! CIRCADIAN SLEEP REGULATION IN ADOLESCENCE

University of Helsinki1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
270
试验地点
1
主要终点
Circadian body temperature rhythm

研究概览

简要总结

Adolescence associates with alterations in sleep-wake organization, such as later circadian phase preference. Simultaneously external pressures, such as evening-driven social activities increase. These may lead to delayed sleep phase, which may cause serious problems for waking up at socially accepted times, and absenteeism from the school may follow. This project aims at tracking risk factors for later circadian regulation problems, characterizing interconnections of biological, psychological and behavioural mechanisms that maintain or induce poor sleep regulation in adolescence, and building a cost-effective, theoretically-based sleep intervention for adolescents with delayed sleep phase. This randomized control trial capitalizes on a new population-based cohort of 16-17-year olds.

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

入选标准

  • •Late bedtime several times per week

排除标准

  • •Chronic disease that affects sleep. Ongoing therapeutic treatment relationship if considered overlapping by the participant

研究组 & 干预措施

Sleep coaching + bright light

Experimental

A combination of the two

干预措施: Bright light (Device)

Control

Experimental

Minimal information on sleep timing

干预措施: Control (Other)

Psychoeducation

Experimental

An extensive psychoeducational platform

干预措施: Psychoeducation (Other)

Bright light

Experimental

Bright light treatment with 10 000 lux at max

干预措施: Bright light (Device)

Gamified intervention

Experimental

A new gamified intervention designed for mobile phones

干预措施: Gamified intervention (Behavioral)

Bright light and gamified intervention

Experimental

A combination of the two

干预措施: Gamified intervention (Behavioral)

Bright light and gamified intervention

Experimental

A combination of the two

干预措施: Bright light (Device)

Sleep coaching

Experimental

A new intervention protocol including a personified approach to solve problems and increase motivation for better sleep behavior

干预措施: Sleep coaching (Behavioral)

Sleep coaching + bright light

Experimental

A combination of the two

干预措施: Sleep coaching (Behavioral)

结局指标

主要结局

Circadian body temperature rhythm

时间窗: 8 weeks

iButton measurement from the wrist

Circadian sleep rhythm

时间窗: 8 weeks

Actigraphy (brand GeneActiv)

次要结局

  • Mood(8 weeks)
  • Insomnia symptoms(8 weeks)
  • Anxiety(8 weeks)
  • Sleep problems(8 weeks)
  • Depression(8 weeks)

研究者

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

Anu-Katriina Pesonen

Professor

University of Helsinki

研究点 (1)

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