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临床试验/NCT06028997
NCT06028997已完成不适用

Implementation of Behavioral and Sleep Hygiene Education With Mindfulness Intervention to Improve Sleep Regularity in Adolescents; is There a Relationship With Anxiety, Depression or Chronotype

Solveig Magnusdottir4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年8月28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
80
试验地点
4
主要终点
Change in sleep regularity and social jetlag from baseline to follow up after 8-weeks of intervention

研究概览

简要总结

Sleep plays a fundamental role in both mental- and physical-health, with good sleep health including adequate duration and quality, appropriate timing, regularity, and absence of sleep disorders. The purpose of this study is to evaluate sleep in adolescent and if brief behavioral and sleep hygiene education with mindfulness intervention improves, sleep timing, sleep duration, sleep quality, anxiety- and depression symptoms.

During adolescence extensive physiological changes happen that make it easier for adolescents to stay up later, that may increase the time it may take them to fall-asleep and developing insomnia symptoms. At the same time psychosocial changes happen, the societal changes in the last decade may even have further amplified late sleep in adolescents, with increase in social media use and evening screen-time. As sleep need is not decreased and with adolescents having to wake up at "socially acceptable times" rather than the endogenous sleep offset time, sleep duration may be shortened causing chronic sleep loss and daytime sleepiness. Insufficient sleep in adolescents may affect their daytime functioning, causing fatigue and memory issues, affect school attendance and academic performance, affect mood, mental- and physical health, cause behavioral dysfunction and has been associated with worse health outcomes, adverse risk behaviors and even increase risk for accidents.This study should advance understanding of sleep in adolescents and if this simple interventions can be effective in improving their sleep and mental health.

详细描述

The study is a prospective cohort-study implementing a brief behavioral and sleep hygiene education with mindfulness intervention in adolescents starting a junior collage (16 years of age). All first year students are invited to participate and those interested, willing to sign a consent and have a consent from a parent/guardian will be included in the study, except if diagnosed with chronic atrial fibrillation or ventricular trigemini, severe uncontrolled asthma, or other pulmonary diseases, or diagnosed with moderate or severe obstructive sleep apnea (OSA) then will be excluded from participating in the study.

Sleep duration, sleep timing (sleep onset and conclusion to calculate sleep mid-time and social jetlag), sleep quality, sleep efficiency and wake after sleep onset will be measured with objective home sleep test for three (3) week-nights and two (2) weekend-nights. Sleepiness, insomnia symptoms, anxiety, depression and chronotype will be evaluated with subjective questionnaires before starting intervention of behavioral and sleep hygiene education and mindfulness training once weekly. After the 8-week intervention participants sleep will be measured, sleepiness, insomnia, anxiety, depression symptoms will be re-evaluated with the same questionnaires and their knowledge of how sleep curtailments may affect health and quality of life will be tested.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • First year student attending a junior collage in Northern Europe (Akureyri Iceland)

排除标准

  • chronic atrial fibrillation or ventricular trigemini,
  • severe uncontrolled asthma or other pulmonary diseases,
  • moderate and severe obstructive sleep apnea (OSA)

结局指标

主要结局

Change in sleep regularity and social jetlag from baseline to follow up after 8-weeks of intervention

时间窗: Baseline and week 9

Sleep duration, sleep onset and sleep conclusions (all measured in hours and minutes) to calculate sleep midpoint on school- and free days, to calculate social jetlag (in hours and minutes)

Chronotype and relationship with sleep duration, anxiety- and depression symptoms

时间窗: Baseline and week 9

Chronotype evaluated with validated sleep questionnaire the Morningness-Eveningness Questionnaire (MEQ), a nineteen-item questionnaire to assess the preferred timing of sleep and activity (outcome presented on scale of 31-86 points) to identify early-, intermediate- and evening chronotypes and evaluate if the different chronotype-groups differ in sleep duration (evaluated in hours and minutes)

Chronotype and relationship with anxiety symptoms

时间窗: Baseline and week 9

Chronotype evaluated with validated sleep questionnaire the Morningness-Eveningness Questionnaire (MEQ), a nineteen-item questionnaire to assess the preferred timing of sleep and activity (outcome presented on scale of 31-86 points) to identify early-, intermediate- and evening chronotypes and evaluate if they differ in anxiety symptoms when evaluated with the general anxiety disorder scale-7 (GAD-7), a seven item validated questionnaire designed to screen for and access severity of anxiety (based on scores from 0-21)

Chronotype and relationship with depression symptoms

时间窗: Baseline and week 9

Chronotype evaluated with validated sleep questionnaire the Morningness-Eveningness Questionnaire (MEQ), a nineteen-item questionnaire to assess the preferred timing of sleep and activity (outcome presented on scale of 31-86 points) to identify early-, intermediate- and evening chronotypes and evaluate if they differ in depression symptoms when evaluated with the patient health questionnaire (PHQ-9), a nine-item validated questionnaire (scores from 0-27), with higher scores indicating more symptoms

次要结局

未报告次要终点

研究者

发起方
Solveig Magnusdottir
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Solveig Magnusdottir

Chief Medical Officer

Akureyri Hospital

研究点 (4)

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