Effects of WiFi Exposure on Sleep in Women

February 19, 2024 updated by: Heidi Danker-Hopfe, Charite University, Berlin, Germany

Effects of WiFi Exposure on Sleep and Sleep Related Memory Consolidation in Young Healthy Women

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.

Study Overview

Status

Suspended

Conditions

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.

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Berlin, Germany, 12203
        • Charité - University Medicine Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 28 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: WiFi - Sham
first intervention WiFi, second intervention sham
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
Exposure system delivers emissions comparable to those from a WiFi access Point close to the bed or sham (no exposure)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Efficiency index
Time Frame: 8 hours
(total Sleep time in % of time in bed)
8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
declarative memory
Time Frame: 8 hours
number of remembered word pairs in the Word Association Task
8 hours
Sleep EEG power
Time Frame: 8 hours
EEG power in the spindle frequency range
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 24, 2020

First Submitted That Met QC Criteria

October 5, 2020

First Posted (Actual)

October 12, 2020

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • EA4/074/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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