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临床试验/NCT05569603
NCT05569603招募中不适用

Effects of Chronobiology-guided Lifestyle Interventions on Insomnia Severity, Cognitive Performance, and Sleepiness in Female Rotating-shift Nurses: a Randomized Controlled Trial

Taipei Veterans General Hospital, Taiwan2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
2
主要终点
insomnia severity

研究概览

简要总结

Poor sleep is closely related to circadian misalignment; shift workers often experience shift work disorder characterized by excessive sleepiness and recurrent shift work schedules-associated insomnia. This study aims to examine the effects of a program of chronobiology-guided lifestyle interventions (CGLI) on insomnia severity, cognitive performance (psychomotor vigilance and processing speed), and sleepiness in female nurses undertaking rotating-shift work.

详细描述

This study will use a parallel-group, randomized, assessor-blind, wait-list controlled design to determine the effects of a program of multimodal lifestyle interventions based on chronobiology, consisting of timed bright light exposure, meal timing manipulations, and sleep hygiene education on insomnia severity, cognitive performance (psychomotor vigilance and processing speed), and sleepiness in female nurses undertaking rotating-shift work.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Females aged 20 to 60 who work full time as a nurse and work a 3-shift rotation, including day shifts, evening shifts, and night shifts in the most recent 6 months.
  • Participants must complain of insomnia symptoms and/or sleepiness in relation to shift work schedule for at least 3 months.
  • Participants must have10 workdays (evening or night shift) within a 14-day period during the study period.

排除标准

  • Active physical diseases.
  • Moderate to severe psychopathology.
  • Medications or treatments that may affect sleep.
  • Pregnant or breastfeeding.
  • Participants must be free of ophthalmic pathology, eye surgery, and diseases affecting the retina or taking photosensitizing drugs.
  • Participants who have been diagnosed with sleep-disordered breathing will be excluded. Sleep-disordered breathing such as obstructive sleep apnea (OSA) will be screened using the snoring, tiredness, observed apnea, high BP, BMI, age, neck circumference, and male gender (STOP-BANG) questionnaire.

结局指标

主要结局

insomnia severity

时间窗: Through study completion, an average of 14days

The Insomnia Severity Index will be used to determine the severity of insomnia. The Insomnia Severity Index with a total score ranging from 0 to 28. A higher Insomnia Severity Index score indicates more severe insomnia.

次要结局

  • The neurobehavioral function of cognitive performance(Through study completion, an average of 14 days)
  • The processing speed of cognitive performance(Through study completion, an average of 14 days)
  • The sleepiness at work(Through study completion, an average of 14 days)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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