Investigation of whether 5G technology affects sleep and sleep-related brain functions: a possible connection to calcium channels in the brain

Switzerland (ICTRP)

ICTRP Trial ID
NCT06998368 (ICTRP)

Official title (approved by ethics committee)
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) (BASEC)

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

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

Disease under investigation
Mediation of 5G Effects on Sleep (ICTRP)

Intervention under investigation
Drug: Nimodipine CapsulesRadiation: 5G RF-EMF (ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator). (ICTRP)

Inclusion/Exclusion criteria
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. (ICTRP)

not available

Primary and secondary end points
Sleep spindle center frequency (ICTRP)

Sex distribution of participants;Age of Participants;Pregnancy status;EEG power spectra during Non-Rapid-Eye-Movement (NREM) sleep;Total sleep time;Neurocognitive performance as assessed in the psychomotor vigilance task (PVT);Heart rate;Handedness of participants;BMI of participants;Highest level of education of participants;Phone call time;Caffeine consumption;Alcohol consumption;Electrohypersensitivity (EHS) status;Sleep disturbances;Comorbidities;Night-shift work;Use of medications;Use of illegal drugs;Use of tobacco products;Subjective sleep quality;Daytime sleepiness;Diurnal preference;Habitual bedtime;Habitual rise time;Reported time to fall asleep;Reported sleep duration;Positive and Negative Affect Schedule;Nocturnal mentation;Depressive tendency;Mental suggestibility tendency;Schizotypal tendency;ADHD tendency;EEG power spectra during wakefulness;EEG power spectra during Rapid Eye Movement (REM) sleep;Aperiodic component of the EEG power spectrum during NREM sleep;Aperiodic component of the EEG power spectrum during REM sleep;Aperiodic component of the EEG power spectrum during wakefulness;Periodic component of the EEG power spectrum during NREM sleep;Periodic component of the EEG power spectrum during REM sleep;Periodic component of the EEG power spectrum during wakefulness;Sleep efficiency;Sleep latency;Wakefulness after sleep onset;Time spent in the different sleep stages;Neurocognitive performance as assessed in the sequential finger tapping task (FTT);Neurocognitive performance as assessed in the visuospatial 2D Object Location Task (OLT);Heart rate variability;Pupil size (ICTRP)

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
Federal Office for the Environment, Switzerland (ICTRP)

Additional contacts
Rachele Maria D'Angelo, M. Sc., rachele.dangelo@pharma.uzh.ch, +41 44 635 59 61 (ICTRP)

Secondary trial IDs
5G-Cav1.2 Sleep (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/study/NCT06998368 (ICTRP)