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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04583397
Other study ID # EA4/074/19
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date December 2024

Study information

Verified date February 2024
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Suspended
Enrollment 34
Est. completion date December 2024
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
Germany Charité - University Medicine Berlin Berlin

Sponsors (2)

Lead Sponsor Collaborator
Charite University, Berlin, Germany Seibersdorf Labor GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sleep Efficiency index (total Sleep time in % of time in bed) 8 hours
Secondary declarative memory number of remembered word pairs in the Word Association Task 8 hours
Secondary Sleep EEG power EEG power in the spindle frequency range 8 hours
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