NCT03074617

Brief Summary

The effect of electromagnetic fields of the latest standard in mobile communication (long term evolution, LTE) on sleep is studied in healthy, young individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 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

January 31, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

5.7 years

First QC Date

February 23, 2017

Last Update Submit

January 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • electroencephalographic power during sleep after LTE exposure

    electroencephalogram (EEG)

    up to 9 hours (approximately 11 p.m. to 8 a.m.)

Study Arms (2)

LTE field

EXPERIMENTAL
Other: LTE field

sham field

SHAM COMPARATOR
Other: sham field

Interventions

electromagnetic field of the latest standard in mobile communication (long term evolution, LTE)

LTE field

no electromagnetic field

sham field

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-30 years
  • German knowledge (reading and writing)
  • Right-handedness
  • Body mass index (BMI) 18.5-25.0 kg/m2
  • Mobile communication (phone calls) less than 2 hours per week
  • Moderate alcohol consumption (less than 5 alcoholic beverages per week)
  • Moderate caffeine consumption (less than 5 caffeinated foods per day, e.g. coke, coffee, energy drinks, green or black tea, chocolate)
  • Informed consent

You may not qualify if:

  • Travels across more than 2 time zones in the last 30 days or during the study
  • Nocturnal shift work
  • Extreme chronotype or extreme sleep duration (less than 5 hours or more than 10 hours on average)
  • Sleep disorders or problems
  • Severe acute or chronic neurological, mental or general health disorders, which might impair the participant's safety or affect the study's outcome
  • Use of medication (regular or during the study), which might affect the study's outcome
  • Recreational drug use
  • Smoking (or other tobacco products)
  • Severe skin allergies
  • Relevant findings in physical examination or during the screening night (e.g. sleep disorders)
  • Participation in an other clinical trial in the last 30 days or during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zurich, Institute of Pharmacology and Toxicology

Zurich, 8057, Switzerland

Location

Related Publications (1)

  • Eicher C, Marty B, Achermann P, Huber R, Landolt HP. Reduced subjective sleep quality in people rating themselves as electro-hypersensitive: An observational study. Sleep Med. 2024 Jan;113:165-171. doi: 10.1016/j.sleep.2023.11.029. Epub 2023 Nov 21.

Study Officials

  • Hans-Peter Landolt

    University of Zurich, Institute of Pharmacology and Toxicology

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

February 23, 2017

First Posted

March 9, 2017

Study Start

January 31, 2017

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

January 30, 2023

Record last verified: 2023-01

Locations