Effects of WiFi Exposure on Sleep in Women

• ClinicalTrials.gov Identifier: NCT04583397
• Recruitment Status: Suspended
• First Posted: October 12, 2020
• Last Update Posted: October 12, 2020
• Sponsor: Charite University, Berlin, Germany
• Collaborator: Seibersdorf Labor GmbH
• Information provided by (Responsible Party): Heidi Danker-Hopfe, Charite University, Berlin, Germany

Study Description

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.

Study Design

• 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

Arms and Interventions

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)

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Germany

Charité - University Medicine Berlin

Berlin, Germany, 12203

Sponsors and Collaborators

Charite University, Berlin, Germany

Seibersdorf Labor GmbH

More Information

• 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
• Last Update Posted: October 12, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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