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临床试验/ACTRN12619001636145
ACTRN12619001636145已完成未知

ovel Insomnia Treatment Experiment (NITE): The effectiveness of incorporating appropriate guidance for sleep wearable in users with insomnia

Monash University0 个研究点目标入组 113 人开始时间: 2019年11月25日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
113

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • (a)18 years old or above;
  • (b)Able to communicate in English;
  • (c)Have regular access to internet, smartphone and email;
  • (d)Experiencing insomnia symptoms (Insomnia Severity Index of 10 or above).

排除标准

  • (a)Participants who endorse symptoms of, or are known to have any of the following sleep disorders as determined by the DUKE Structured Interview for Sleep Disorders (DSISD):
  • oSleep apnea: loud snoring, or observed gasping or pauses in breathing, or previously diagnosed with apnea hypopnea index > 15 but not/inadequately treated;
  • oPreviously diagnosed Periodic Limb Movement Disorder with arousal index > 15;
  • oRestless Legs Syndrome occurring 3 times/week, with duration of at least one month;
  • oCircadian Rhythm Sleep-Wake Disorders. These include irregular and non-24-hour sleep-wake types, advanced (if habitual bedtime is earlier than 8pm and habitual wake time earlier than 4am, occasional deviation allowed) and delayed (if habitual bedtime later than 3am and habitual wake time later than 11am, occasional deviation allowed) sleep phase types;
  • (b)Participants with current fixed night shift work between midnight and 5am, or current rotating work schedules that require night shifts during the study period.
  • (c)Participants who are at risk determined by individuals who select either moderate or high on the suicidal ideation item on the baseline questionnaire.
  • (d)Participants who have used Fitbit in the month prior to participation.

研究者

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