Effects of WiFi Exposure on Sleep in Women

NCT04583397 | Suspended

• 1 other identifier: EA4/074/19
• Study Type: interventional
• Target: 34
• 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 in young healthy women.

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

• Sleep Efficiency index

  (total Sleep time in % of time in bed)

  8 hours

Secondary Outcomes (2)

• declarative memory

  8 hours

• Sleep EEG power

  8 hours

Study Arms (2)

Experimental: WiFi - Sham

EXPERIMENTAL

first intervention WiFi, second intervention sham

Other: radio frequency electromagnetic fields

Experimental: Sham - WiFi

EXPERIMENTAL

first Intervention sham, second Intervention WiFi

Other: radio frequency electromagnetic fields

Interventions

radio frequency electromagnetic fields OTHER

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

Experimental: Sham - WiFi; Experimental: WiFi - Sham

Eligibility Criteria

• Age: 20 Years - 30 Years
• Gender Eligibility Details: only women will be included, a corresponding study for men has already been completed
• 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
• Seibersdorf Labor GmbH: collaborator

Study Sites (1)

Charité - University Medicine Berlin

Berlin, 12203, Germany

Location

Study Design

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

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 12, 2020
• Study Start: February 1, 2020
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)