Effects of WiFi Exposure on Sleep in Women

NCT ID: NCT04583397

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2024-12-31

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.

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.

Conditions

Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Experimental: WiFi - Sham

first intervention WiFi, second intervention sham

Group Type: EXPERIMENTAL

radio frequency electromagnetic fields

Intervention Type: OTHER

Exposure system delivers emissions comparable to those from a WiFi access Point close to the bed or sham (no exposure)

Experimental: Sham - WiFi

first Intervention sham, second Intervention WiFi

Group Type: EXPERIMENTAL

radio frequency electromagnetic fields

Intervention Type: OTHER

Exposure system delivers emissions comparable to those from a WiFi access Point close to the bed or sham (no exposure)

Interventions

radio frequency electromagnetic fields

Exposure system delivers emissions comparable to those from a WiFi access Point close to the bed or sham (no exposure)

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Seibersdorf Labor GmbH

INDUSTRY

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Heidi Danker-Hopfe

Head of Competence Center for Sleep Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charité - University Medicine Berlin

Berlin, , Germany

Countries

Germany

Other Identifiers

EA4/074/19

Identifier Type: -

Identifier Source: org_study_id