NCT02896491

Brief Summary

To investigate possible effects of radio frequency electromagnetic fields on EEG activity during sleep and on Brain function during wake (EEG in the resting state condition, slow EEG potentials, auditory evoked potentials) and cognitive performance measures in test of selective attention, divided attention and working memory in healthy elderly males (60 - 80 years).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

1.8 years

First QC Date

May 27, 2016

Last Update Submit

February 9, 2021

Conditions

Non-Ionizing Radiation

Outcome Measures

Primary Outcomes (1)

  • sleep EEG (power)

    during exposure for 8 hours

Secondary Outcomes (1)

  • resting state Waking EEG (power)

    during exposure 4 hours

Study Arms (3)

GSM 900 MHz exposure

EXPERIMENTAL

Radiation: Exposure with non-ionizing electromagnetic fields exposure with GSM 900 MHz (2W/kg)

Radiation: Exposure with non-ionizing electromagnetic fields

TETRA 400 MHz exposure

EXPERIMENTAL

Radiation: Exposure with non-ionizing electromagnetic fields: exposure with TETRA (6W/kg)

Radiation: Exposure with non-ionizing electromagnetic fields

Sham exposure

SHAM COMPARATOR

Radiation: Exposure with non-ionizing electromagnetic fields: exposure with 0 W/kg

Radiation: Exposure with non-ionizing electromagnetic fields

Interventions

Exposure with non-ionizing electromagnetic fieldsRADIATION

In a cross-over design subjects will be exposed to sham (placebo), GSM 900 MHz (2W/kg) and TETRA (6W/kg)

GSM 900 MHz exposureSham exposureTETRA 400 MHz exposure

Eligibility Criteria

Age60 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy male subjects (age 60 - 80 years)
  • right handedness
  • alpha EEG as resting state EEG
  • non-smokers

You may not qualify if:

  • acute illness
  • severe neurological, psychiatric or internal disease
  • CNS active medication
  • sleep disorders
  • drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Competence Center Sleep Medicine

Berlin, 12203, Germany

Location

Related Publications (2)

  • Eggert T, Dorn H, Sauter C, Schmid G, Danker-Hopfe H. RF-EMF exposure effects on sleep - Age doesn't matter in men! Environ Res. 2020 Dec;191:110173. doi: 10.1016/j.envres.2020.110173. Epub 2020 Sep 12.

    PMID: 32931791DERIVED

  • Danker-Hopfe H, Dorn H, Sauter C, Schmid G, Eggert T. An experimental study on effects of radiofrequency electromagnetic fields on sleep in healthy elderly males and females: Gender matters! Environ Res. 2020 Apr;183:109181. doi: 10.1016/j.envres.2020.109181. Epub 2020 Jan 24.

    PMID: 32014649DERIVED

Study Officials

  • Blanka Pophof, Ph.D

    Federal Office of Radiation Protection

    STUDY CHAIR

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 GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Competence Center of Sleep Medicine and Sleep Research

Study Record Dates

First Submitted

May 27, 2016

First Posted

September 12, 2016

Study Start

May 1, 2016

Primary Completion

January 31, 2018

Study Completion

May 31, 2019

Last Updated

February 10, 2021

Record last verified: 2021-02

Locations

DE(1)