- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03074617
Electromagnetic Field Effects of Mobile Communication (LTE) on Sleep in the Context of Genetic Variation
January 27, 2023 updated by: University of Zurich
The effect of electromagnetic fields of the latest standard in mobile communication (long term evolution, LTE) on sleep is studied in healthy, young individuals.
Study Overview
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Zurich, Switzerland, 8057
- University of Zurich, Institute of Pharmacology and Toxicology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LTE field
|
electromagnetic field of the latest standard in mobile communication (long term evolution, LTE)
|
Sham Comparator: sham field
|
no electromagnetic field
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
electroencephalographic power during sleep after LTE exposure
Time Frame: up to 9 hours (approximately 11 p.m. to 8 a.m.)
|
electroencephalogram (EEG)
|
up to 9 hours (approximately 11 p.m. to 8 a.m.)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hans-Peter Landolt, University of Zurich, Institute of Pharmacology and Toxicology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 31, 2017
Primary Completion (Actual)
September 30, 2022
Study Completion (Actual)
September 30, 2022
Study Registration Dates
First Submitted
February 23, 2017
First Submitted That Met QC Criteria
March 3, 2017
First Posted (Actual)
March 9, 2017
Study Record Updates
Last Update Posted (Estimate)
January 30, 2023
Last Update Submitted That Met QC Criteria
January 27, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- LTE-Sleep
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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