- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04248140
Effects of WiFi Exposure on Sleep
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Berlin, Germany, 12203
- Charité - University Medicine Berlin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WiFi - Sham
first Intervention WiFi, second intervention sham
|
Exposure system delivers emissions comparable to those from WiFi access point close to the bed or sham (nor exposure)
|
Experimental: Sham - WiFi
first intervention sham, second intervention WiFi
|
Exposure system delivers emissions comparable to those from WiFi access point close to the bed or sham (nor exposure)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sleep Efficiency index (total sleep time in % of time in bed)
Time Frame: 8 hours
|
Summary variable describing objective sleep quality
|
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 Pair Association Test
|
8 hours
|
sleep EEG power
Time Frame: 8 hours
|
power spectra of the sleep EEG
|
8 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EA4/075/19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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