Effects of WiFi Exposure on Sleep

NCT04248140 | Completed

• 1 other identifier: EA4/075/19
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Keywords

radio frequency electromagnetic fields, volunteers

Outcome Measures

Primary Outcomes (1)

• sleep Efficiency index (total sleep time in % of time in bed)

  Summary variable describing objective sleep quality

  8 hours

Secondary Outcomes (2)

• declarative memory

  8 hours

• sleep EEG power

  8 hours

Study Arms (2)

WiFi - Sham

EXPERIMENTAL

first Intervention WiFi, second intervention sham

Other: radio frequency electromagnetic field

Sham - WiFi

EXPERIMENTAL

first intervention sham, second intervention WiFi

Other: radio frequency electromagnetic field

Interventions

radio frequency electromagnetic field OTHER

Exposure system delivers emissions comparable to those from WiFi access point close to the bed or sham (nor exposure)

Sham - WiFi; WiFi - Sham

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - University Medicine Berlin

Berlin, 12203, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Competence Center of Sleep Medicine

Model Details: Two exposures (WiFi and sham) are applied in a randomized double-blind counterbalanced cross-over study

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 30, 2020
• Study Start: September 1, 2019
• Primary Completion: April 14, 2020
• Study Completion: May 31, 2020
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)