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Effects of WiFi Exposure on Sleep in Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04583397
Recruitment Status : Suspended (Corona)
First Posted : October 12, 2020
Last Update Posted : October 12, 2020
Sponsor:
Collaborator:
Seibersdorf Labor GmbH
Information provided by (Responsible Party):
Heidi Danker-Hopfe, Charite University, Berlin, Germany

Brief Summary:
Effects of Wifi exposure on sleep and sleep-related memory consolidation are investigated in a double-blind, sham-controlled fully counterbalanced study design in young healthy women.

Condition or disease Intervention/treatment Phase
Sleep Other: radio frequency electromagnetic fields Not Applicable

Detailed Description:

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.

The study aims to analyse possible sex differences in WiFi exposure effects on sleep and sleep related memory consolidation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of WiFi Exposure on Sleep and Sleep Related Memory Consolidation in Young Healthy Women
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: Experimental: WiFi - Sham
first intervention WiFi, second intervention sham
Other: radio frequency electromagnetic fields
Exposure system delivers emissions comparable to those from a WiFi access Point close to the bed or sham (no exposure)

Experimental: Experimental: Sham - WiFi
first Intervention sham, second Intervention WiFi
Other: radio frequency electromagnetic fields
Exposure system delivers emissions comparable to those from a WiFi access Point close to the bed or sham (no exposure)




Primary Outcome Measures :
  1. Sleep Efficiency index [ Time Frame: 8 hours ]
    (total Sleep time in % of time in bed)


Secondary Outcome Measures :
  1. declarative memory [ Time Frame: 8 hours ]
    number of remembered word pairs in the Word Association Task

  2. Sleep EEG power [ Time Frame: 8 hours ]
    EEG power in the spindle frequency range



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   only women will be included, a corresponding study for men has already been completed
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04583397


Locations
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Germany
Charité - University Medicine Berlin
Berlin, Germany, 12203
Sponsors and Collaborators
Charite University, Berlin, Germany
Seibersdorf Labor GmbH
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Responsible Party: Heidi Danker-Hopfe, Head of Competence Center for Sleep Medicine, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04583397    
Other Study ID Numbers: EA4/074/19
First Posted: October 12, 2020    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No