跳至主要内容
临床试验/NCT04248140
NCT04248140已完成不适用

Effects of WiFi Exposure on Sleep

Charite University, Berlin, Germany2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
sleep Efficiency index (total sleep time in % of time in bed)

研究概览

简要总结

Effects of Wifi exposure on sleep and sleep-related Memory consolidation are investigated in a double-blind, sham-controlled fully counterbalanced study design.

详细描述

Introduction

Since several years Wireless Local Networks (WLAN, WiFi) are widely spread and operated in households. Many people feel that the presence of radiofrequency technologies impairs their health. Sleep problems are among the most often complained complaints. The present study aims to contribute to answer the question, whether biological effects of a WiFi exposure can be assessed by objective measures. The results of this study will expand the database on possible acute effects of WiFi exposure and thus qualitatively contribute to the discussion whether sleep is affected by exposure from radiofrequency electromagnetic fields.

Methods: A double-blind, sham-controlled experiment in the sleep laboratory with exposure conditions delivered in a balanced randomized cross-over design. Subjective sleep quality of volunteers is assessed by questionnaires. Macro- and microstructure of sleep are measured by polysomnography. Furthermore, a possible impact on sleep related memory consolidation is tested. To do so declarative, procedural and emotional memory tasks are used. Exposure is delivered by a specially developed system, which simulates field strengths and signals occurring in a subject sleeping in the close proximity of a WiFi-access point. This exposure system is necessary to allow for a double-blind implementation and monitoring as well as for the realization of defined exposure parameters.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Only right-handed
  • non-smokers
  • Pittsburgh Sleep Quality Index (PSQI) score < 5
  • no extreme morning/evening preference [Morningness-Eveningness Questionnaire (MEQ) score ≥ 31 or ≤ 69
  • no indication of depression or somatic symptoms as assessed by a medical examination and validated questionnaires [Patient Health Questionnaires (PHQ-9 and PHQ-15) scores ≤ 5 and ≤ 10, respectively

排除标准

  • history of a psychiatric disorder,
  • history of a neurological and/or sleep disorder
  • excessive daytime sleepiness [Epworth Sleepiness Scale (ESS) score > 9;
  • non-regular sleep-wake schedule as assessed by a sleep diary
  • a regular intake of medication that affects the central nervous system, excessive caffeine and/or alcohol consumption, regular and occasional drug use,
  • metal implants
  • periodic leg movement arousal index > 10/h in the Adaptation night
  • apnoea-hypopnoea-index > 5/h in the Adaptation night.

结局指标

主要结局

sleep Efficiency index (total sleep time in % of time in bed)

时间窗: 8 hours

Summary variable describing objective sleep quality

次要结局

  • declarative memory(8 hours)
  • sleep EEG power(8 hours)

研究者

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

Heidi Danker-Hopfe

Head Competence Center of Sleep Medicine

Charite University, Berlin, Germany

研究点 (2)

Loading locations...

相似试验