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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Nimodipine Capsules
  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.
• Лучевая терапия 5G RF-EMF
  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.

Первичные конечные точки

• Sleep spindle center frequency [Срок оценки: 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]

Вторичные конечные точки (12)

• Sex distribution of participants [Срок оценки: At the large-scale genetic screening]
• Age of Participants [Срок оценки: At the large-scale genetic screening]
• Pregnancy status [Срок оценки: At the large-scale genetic screening]
• EEG power spectra during Non-Rapid-Eye-Movement (NREM) sleep [Срок оценки: 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 [Срок оценки: 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]
• Neurocognitive performance as assessed in the psychomotor vigilance task (PVT) [Срок оценки: Assessed on each of the four experimental nights, pre- and post-sleep]
• Heart rate [Срок оценки: Assessed on each of the four experimental nights, from electrocardiographic recordings during pre-sleep exposure and polysomnographic overnight recordings]
• Handedness of participants [Срок оценки: At the large-scale genetic screening]
• BMI of participants [Срок оценки: At the large-scale genetic screening]
• Highest level of education of participants [Срок оценки: At the large-scale genetic screening]
• Phone call time [Срок оценки: At the large-scale genetic screening]
• Caffeine consumption [Срок оценки: At the large-scale genetic screening]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Швейцария · 1 центр

• University of Zurich, Institute of Pharmacology and Toxicology — Zurich

Идентификаторы

NCT: NCT06998368 · 5G-Cav1.2 Sleep

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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