A Causal Role for Voltage-gated Cav1.2 Calcium Channels in Mediating 5G FR1 Effects on Sleep-associated Brain Health in Humans

NCT06998368 | Recruiting DMC

• 1 other identifier: 5G-Cav1.2 Sleep
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Electromagnetic fields (EMFs) generated by the use of 5G technology influence certain sleep characteristics, especially in individuals carrying a specific genetic variant of a protein in the brain that regulates the activity of nerve cells. This protein is a voltage-gated calcium channel called CaV1.2 and could be involved in the effects of 5G technology on sleep. The calcium channel CaV1.2 can be selectively blocked by the drug nimodipine. To demonstrate that CaV1.2 is indeed involved in the effects of 5G technology on sleep, the researchers are investigating in this study, with healthy subjects carrying the sought-after genetic variant, whether the administration of nimodipine and thus the blockade of the calcium channel before exposure mitigates or eliminates the effects of EMF on sleep health.

Conditions

Mediation of 5G Effects on Sleep

Keywords

5G; CACNA1C; CaV1.2; electromagnetic; EMF; nimodipine; RF-EMF; sleep; rs7304986; voltage-gated calcium channel; brain

Outcome Measures

Primary Outcomes (1)

• Sleep spindle center frequency

  In previous research, the investigators detected a positive shift in the sleep spindle center frequency (during NREM sleep phase) after 30-min pre-sleep exposure to a 5G signal at 3600 MHz, 100 MHz bandwidth in heterozygous T/C allele-carriers (rs7304986) compared to sham. The sleep spindle center frequency is a parameter that can be extracted from the overnight electroencephalographic recordings.

  Assessed on each of the four experimental nights, from overnight electroencephalographic recordings following randomized combinations of drug (nimodipine or placebo) and RF-EMF exposure (5G or sham), with a minimum of 3 days washout between sessions

Secondary Outcomes (49)

• Sex distribution of participants

  At the large-scale genetic screening

• Age of Participants

  At the large-scale genetic screening

• Pregnancy status

  At the large-scale genetic screening

• EEG power spectra during Non-Rapid-Eye-Movement (NREM) sleep

  Assessed on each of the four experimental nights, from overnight electroencephalographic recordings following randomized combinations of drug (nimodipine or placebo) and RF-EMF exposure (5G or sham), with a minimum of 3 days washout between sessions

• Total sleep time

  Assessed on each of the four experimental nights, from overnight electroencephalographic recordings following randomized combinations of drug (nimodipine or placebo) and RF-EMF exposure (5G or sham), with a minimum of 3 days washout between sessions

Study Arms (24)

Arm2

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm1

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining eighteen sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm3

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm4

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm6

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm7

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm8

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm9

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm10

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm11

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm12

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm5

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm13

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm14

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm15

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm16

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm17

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm18

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm19

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm20

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm21

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm22

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm23

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Arm24

OTHER

The study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.

Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

Interventions

Nimodipine Capsules DRUG

Two times 30 mg nimodipine or placebo will be administered orally 45 minutes prior to the start of the 5G FR1 exposure. The verum and placebo capsules will look the same, in order to preserve the double-blinding.

Arm1; Arm10; Arm11; Arm12; Arm13; Arm14; Arm15; Arm16; Arm17; Arm18; Arm19; Arm2; Arm20; Arm21; Arm22; Arm23; Arm24; Arm3; Arm4; Arm5; Arm6; Arm7; Arm8; Arm9

5G RF-EMF RADIATION

Participants will be exposed to a standardized electromagnetic field of the latest mobile radio standard (5G) or a sham field for 30 minutes on each of the experimental nights. The active field is characterized by 3.6 GHz frequency \[TDD\] with 100 MHz bandwidth, 12-14 Hz modulation and is comparable to a phone call with a commercially available, modern cell phone. Both the 5G and sham exposures are performed with the same exposure apparatus, according to a double-blind study design.

Arm1; Arm10; Arm11; Arm12; Arm13; Arm14; Arm15; Arm16; Arm17; Arm18; Arm19; Arm2; Arm20; Arm21; Arm22; Arm23; Arm24; Arm3; Arm4; Arm5; Arm6; Arm7; Arm8; Arm9

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For the first part of the study (genotyping and questionnaires):
• Age: 20-40 years old.
• German and/or English language skills (reading and writing)
• Informed Consent as documented by signature
• For the second and third party of the study:
• Completion of the first part of the present study or of the precursor study (BASEC-ID: 2016-02049)
• CACNA1C rs7304986 T/C allele-carrier
• Male gender
• Female gender if using hormonal contraception for the duration of the study (e.g., pill as combination/single preparation, three-month injection, hormonal IUD, hormonal implant, hormonal patch)
• Right-handedness
• Body Mass Index (BMI): BMI comprised between 17.0 kg/m2 and 26.0 kg/m2
• Moderate alcohol consumption (less than 5 reported alcoholic drinks per week)
• Moderate caffeine consumption (less than 3 reported caffeinated beverage or food products per day such as cola, coffee, energy drinks, green and black tea, chocolate)
• Informed Consent as documented by signature.

You may not qualify if:

• For the second and third party of the study:
• Travel with a time difference of more than 2 time zones in the last 30 days before study entry or during the study period
• Shift work at night
• Extreme chronotype or duration of sleep (5 hours \< reported habitual sleep duration per night \> 10 hours)
• Known sleep disorders or diseases
• Serious acute or chronic neurological, mental, or general medical conditions that, in the opinion of the investigator, may pose a risk to participation or affect study measurements
• Use of medications (regularly or during the study period) that, in the opinion of the investigator, may affect study measurements.
• Use of illegal drugs
• Smoking (or other tobacco use)
• Known or suspected non-compliance with the investigators' indications
• Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc.
• Severe skin allergies or hypersensitivities
• Contraindications to nimodipine, e.g., known hypersensitivity or allergy to nimodipine or any of the excipients
• Other cases in which the use of nimodipine is discouraged according to the summary of product characteristics (SPC)
• Women who are pregnant or breast feeding

Sponsors & Collaborators

• Hans-Peter Landolt: lead
• Federal Office for the Environment, Switzerland: collaborator

Study Sites (1)

University of Zurich, Institute of Pharmacology and Toxicology

Zurich, Canton of Zurich, 8057, Switzerland

RECRUITING

Related Links

• Pre-print of our previous research project, providing the background for the current study

MeSH Terms

Interventions

Nimodipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nicotinic Acids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. sc. nat.

Model Details: Each participant of the sleep study will undergo 4 experimental night recordings. On each of the experimental nights, one unique combination of two different interventions will be applied: active exposure to 5G RF-EMF or sham and administration of nimodipine (i.e. verum) or placebo. The four combinations will be: * placebo + sham exposure * placebo + active exposure * verum + sham exposure * verum + active exposure. The sequence order of the 4 nights conditions will be randomized.

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 31, 2025
• Study Start: October 22, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)