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临床试验/NCT03114072
NCT03114072进行中(未招募)不适用

Nightly Light Exposure in Pregnancy: Blue-blocking Glasses as an Intervention to Ease Sleep Disturbances and to Improve Mood

University of Bergen2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
2
主要终点
Sleep diary

研究概览

简要总结

Sleep disturbances are common in pregnancy, and the incidence increases during the third trimester. Light and specially the blue wavelengths of light, is affecting sleep and the circadian rhythm. The main aim of this randomized controlled study is to investigate the effect of Blue-blocking glasses (BB-glasses) used in the evening and night on sleep and mood in pregnant women in the third trimester. The outcome measures assess sleep variables, alertness, melatonin level, sleepiness (subjectively), mood and symptoms of anxiety and depression. In addition we want to measure the pregnancy related sleep problems, alcohol intake, physical activity and perceives stress in the study population, and the association with daily/nightly light exposure.

详细描述

Several hormonal and mechanical influences can cause insomnia in pregnancy, and insomnia has been reported by 62% of pregnant women, a number that is significantly higher than found in the general population (10-15%). Disrupted sleep among pregnant women also includes nocturia (a frequent need to get up and urinate at night), dyspnea (shortness of breath), nasal congestion, muscular aches and pelvic pains, fetal activity, leg cramps as well as reflux.

Artificial light in the evening and during the night increases alertness, disturbs sleep, shifts the timing of the circadian clock and impairs the brains' restorative slow waves during deep sleep. Recent studies have however shown that use of BB-glasses in the evening improves sleep quality (subjectively reported) among persons with insomnia, and prevent alertness caused by blue-light emitting screens which are part of devices such as smart-phones and tablets.

This project will contribute with new knowledge on how filtering nightly light exposure in pregnant women in their third trimester affects their sleep and mood. Importantly, the project initiates new research on a potential non-pharmacological treatment of sleep disturbances by blocking blue wavelengths of light in the evening and during nocturnal awakenings. Blue light is known to increase alertness through a recently described retinal receptor; the intrinsically photoresponsive retinal ganglion cell (IpRGC), specialized for detecting daytime light signal. This project is highly innovative and may have significant practical implications Due to the variety of aims and outcome measures, we plan to present the outcomes in separate articles.

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
Double (Participant, Investigator)

盲法说明

Consenting participants will be randomized (by www.randomizer.org) to either intervention/control condition. The intervention- and control glasses will be covered in the same looking wrapping, done by a third person, which will blind the investigator as well.

入排标准

性别
Female
接受健康志愿者

入选标准

  • nulliparous women
  • expecting one child
  • being in the third trimester of a normal pregnancy
  • able to wear an actigraph during daytime and nighttime
  • able to fill out a questionnaire in Norwegian

排除标准

  • somatic or psychiatric disorders
  • fever and other health conditions affecting sleep
  • working at night during the study protocol

结局指标

主要结局

Sleep diary

时间窗: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31

Daily subjective estimates of sleep variables, and will be assessed every morning.

Change in motor activity measured by using Actigraphy.

时间窗: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31

Objective measure by Actiwatch Spectrum from Philips Respironics. The participants will use the Actiwatch for the whole study period of three weeks.

Melatonin level

时间窗: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31

Measured by saliva samples.

次要结局

  • Bergen Insomnia Scale (BIS)(3 weeks in the third trimester of pregnancy, mainly gestational week 28-31)
  • Karolinska Sleepiness Scale (KSS)(3 weeks in the third trimester of pregnancy, mainly gestational week 28-31)
  • Evening activation(3 weeks in the third trimester of pregnancy, mainly gestational week 28-31)
  • Sleepiness (subjectively)(3 weeks in the third trimester of pregnancy, mainly gestational week 28-31)
  • Mood(3 weeks in the third trimester of pregnancy, mainly gestational week 28-31)
  • The Beck Anxiety Inventory (BAI)(3 weeks in the third trimester of pregnancy, mainly gestational week 28-31)
  • The Beck Depression Inventory-II (BAI-II)(3 weeks in the third trimester of pregnancy, mainly gestational week 28-31)
  • Common pregnancy complaints Questionnaire(3 weeks in the third trimester of pregnancy, mainly gestational week 28-31)
  • Cortisol level(3 weeks in the third trimester of pregnancy, mainly gestational week 28-31)
  • Alpha Amylase level(3 weeks in the third trimester of pregnancy, mainly gestational week 28-31)

研究者

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

Randi Liset

Principal Investigator

University of Bergen

研究点 (2)

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