A Causal Role for Voltage-gated Cav1.2 Calcium Channels in Mediating 5G FR1 Effects on Sleep-associated Brain Health in Humans (5G Cav12 Sleep)

Hans-Peter Landolt

Status: Enrolling

Conditions: Mediation of 5G Effects on Sleep

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06998368

5G-Cav1.2 Sleep

Details and patient eligibility

About

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.

Full description

This study tests a causal role of voltage-gated CaV1.2 calcium channels in mediating the effects of a 5G electromagnetic field on sleep-related brain health in humans.

The study comprises a large-scale genetic screening in order to select the allele-carriers, a sleep screening night, and four experimental nights where participants are exposed to either an active 5G field or sham, combined with either nimodipine (which is a brain-penetrant L-type calcium channel blocker) or placebo. Participants will undergo polysomnographic recordings, high-density electroencephalography (EEG) during wake, peripheral measurements, cognitive and neuropsychiatric assessments.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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
• Participation in another clinical trial in the last 30 days prior to inclusion or during the present study
• 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
• Intention to become pregnant during the course of the study
• Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases (Note: Female participants who are surgically sterilized / hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential)
• Sleep apnea and nocturnal myoclonus index of ≥ 5 per hour of sleep (as assessed during the screening night)
• Sleep efficiency < 80% (as assessed during the screening night)
• Other relevant findings in the screening/adaptation night (e.g., indications of sleep disorders), which in the opinion of the investigator may pose a risk for participation or influence the study measurements.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 24 patient groups

Arm2

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm1

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm3

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm4

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm6

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm7

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm8

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm9

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm10

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm11

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm12

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm5

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm13

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm14

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm15

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm16

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm17

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm18

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm19

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm20

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm21

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm22

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm23

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules

Arm24

Other group

Description:

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.

Treatment:

Radiation: 5G RF-EMF

Drug: Nimodipine Capsules