Electromagnetic Field Effects of Mobile Communication (LT... | NCT03074617

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

NCT03074617

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Jan 30, 2023Actual

Enrollment

34Actual

Phase

Not Applicable

Conditions

Sleep

Interventions

LTE field
sham field

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2017Actual

Primary Completion Date

Sep 30, 2022Actual

Completion Date

Sep 30, 2022Actual

First Submitted Date

Feb 23, 2017

First Submission Date that Met QC Criteria

Mar 3, 2017

First Posted Date

Mar 9, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2023

Last Update Posted Date

Jan 30, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LTE field	Experimental		Other: LTE field
sham field	Sham Comparator		Other: sham field

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LTE field	Other	electromagnetic field of the latest standard in mobile communication (long term evolution, LTE)	LTE field

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
electroencephalographic power during sleep after LTE exposure	electroencephalogram (EEG)	up to 9 hours (approximately 11 p.m. to 8 a.m.)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans-Peter Landolt	University of Zurich, Institute of Pharmacology and Toxicology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Zurich, Institute of Pharmacology and Toxicology		Zurich		8057	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38029625	Derived	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.