Effects of WiFi Exposure on Sleep in Women

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04583397
• Other study ID #: EA4/074/19
• Status: Suspended
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Sleep

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