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Electromagnetic Field Effects of Mobile Communication (LTE) on Sleep in the Context of Genetic Variation

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ClinicalTrials.gov Identifier: NCT03074617
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Sleep Other: LTE field Other: sham field Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Electromagnetic Field Effects of Mobile Communication (LTE) on Sleep in the Context of Genetic Variation
Actual Study Start Date : January 31, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LTE field Other: LTE field
electromagnetic field of the latest standard in mobile communication (long term evolution, LTE)

Sham Comparator: sham field Other: sham field
no electromagnetic field




Primary Outcome Measures :
  1. electroencephalographic power during sleep after LTE exposure [ Time Frame: up to 9 hours (approximately 11 p.m. to 8 a.m.) ]
    electroencephalogram (EEG)



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074617


Contacts
Contact: Hans-Peter Landolt, Prof. Dr. +41 (44) 635 59 53 landolt@pharma.uzh.ch

Locations
Switzerland
University of Zurich, Institute of Pharmacology and Toxicology Recruiting
Zurich, Switzerland, 8057
Contact: Hans-Peter Landolt, Prof. Dr.    +41 (44) 635 59 53    landolt@pharma.uzh.ch   
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Hans-Peter Landolt University of Zurich, Institute of Pharmacology and Toxicology

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03074617     History of Changes
Other Study ID Numbers: LTE-Sleep
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No