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Mediation of 5G Effects on Sleep5G Cav12 SleepNCT06998368

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

A study testing Nimodipine Capsules and 5G RF-EMF in people with Mediation of 5G Effects on Sleep, run by Hans-Peter Landolt at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Mediation of 5G Effects on Sleep
What is being tested?
Nimodipine Capsules and 5G RF-EMF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSwitzerland
Study dates
22 Oct 2024to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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
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  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Switzerland1 site, 1 recruiting
  • University of Zurich, Institute of Pharmacology and Toxicology

    Zurich, Canton of Zurich, 8057

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

    Hans-Peter Landolt, Prof. Dr. sc. nat., +41 44 635 59 53, landolt@pharma.uzh.ch

    Recruiting

Other trials in Switzerland

About this study

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.

Read the detailed 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.

Being tested
Nimodipine Capsules, 5G RF-EMF
Keywords
5G, CACNA1C, CaV1.2, electromagnetic, EMF, nimodipine, RF-EMF, sleep, rs7304986, voltage-gated calcium channel, brain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nimodipine CapsulesDrug

    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.

  • 5G RF-EMFRadiation

    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.

Study groups in NCT06998368
Study groupRoleWhat they receive
Arm2OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm1OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm3OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm4OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm6OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm7OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm8OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm9OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm10OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm11OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm12OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm5OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm13OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm14OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm15OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm16OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm17OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm18OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm19OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm20OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm21OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm22OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm23OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF
Arm24OtherThe 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.
Receives: Drug: Nimodipine Capsules; Radiation: 5G RF-EMF

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. Sex distribution of participants

    Self-reported biological sex (male or female) is recorded during the large-scale genetic screening (first study part) via an online questionnaire.

    Measured: At the large-scale genetic screening

  2. Age of Participants

    Age is recorded in years based on the year of birth provided during the large-scale genetic screening (first study part) via an online questionnaire.

    Measured: At the large-scale genetic screening

  3. Pregnancy status

    Female participants report current pregnancy status during the large-scale genetic screening (first study part) via an online questionnaire.

    Measured: At the large-scale genetic screening

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

    Power spectra will be computed from artifact-free EEG data recorded during NREM sleep. Spectral power (µV²/Hz) will be computed in standard frequency bands.

    Measured: 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

  5. Total sleep time

    Sleep electroencephalographic data allow to extract total sleep time (min) (total amount of time spent asleep)

    Measured: 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

  6. Neurocognitive performance as assessed in the psychomotor vigilance task (PVT)

    The PVT is administered before and after sleep at each experimental night and provides a score reflecting sustained or vigilant attention performance.

    Measured: Assessed on each of the four experimental nights, pre- and post-sleep

  7. Heart rate

    Heart rate (bpm) is extracted from electrocardiographic recording during exposure and from polysomnographic overnight recordings

    Measured: Assessed on each of the four experimental nights, from electrocardiographic recordings during pre-sleep exposure and polysomnographic overnight recordings

  8. Handedness of participants

    Participants report their handedness (right-handed or left-handed) during the large-scale genetic screening (first study part) via an online questionnaire.

    Measured: At the large-scale genetic screening

  9. BMI of participants

    Self-reported height (in centimeters) and weight (in kilograms) of participants is reported during the large-scale genetic screening (first study part) via an online questionnaire. From Height and Weight, BMI is calculated.

    Measured: At the large-scale genetic screening

  10. Highest level of education of participants

    The highest level of education of participants (elementary school, professional school, high school, university of applied sciences and arts, or university) is self-reported during the large-scale genetic screening (first study part) via an online questionnaire.

    Measured: At the large-scale genetic screening

  11. Phone call time

    Participants report their phone call time without headphones (Not at all, Less than 1 hour per week, 1-2 hours per week or more than 2 hours per week) during the large-scale genetic screening (first study part) via an online questionnaire.

    Measured: At the large-scale genetic screening

  12. Caffeine consumption

    Participants report their caffeine consumption (None, 1-2 caffeinated foods or beverages per day, 3-5 caffeinated foods or beverages per day or More than 5 caffeinated foods or beverages per day) during the large-scale genetic screening (first study part) via an online questionnaire.

    Measured: At the large-scale genetic screening

  13. Alcohol consumption

    Participants report their alcohol consumption (None, Less than 1 glass per week, 1-2 glasses per week, 3-5 glasses per week or More than 5 glasses per week) during the large-scale genetic screening (first study part) via an online questionnaire.

    Measured: At the large-scale genetic screening

  14. Electrohypersensitivity (EHS) status

    Participants report their EHS status during the large-scale genetic screening (first study part) via filling out the online questionnaire by M. Röösli, E. Mohler, and P. Frei (2010).

    Measured: At the large-scale genetic screening

  15. Sleep disturbances

    The presence of sleep disturbances is self-reported by participants during the large-scale genetic screening (first study part) via an online questionnaire.

    Measured: At the large-scale genetic screening

  16. Comorbidities

    Participants self-report the presence of comorbidities during the large-scale genetic screening (first study part) via an online questionnaire.

    Measured: At the large-scale genetic screening

  17. Night-shift work

    Participants report if they engage in night shift work during the large-scale genetic screening (first study part) via an online questionnaire.

    Measured: At the large-scale genetic screening

  18. Use of medications

    Self-reported use of medication is recorded during the large-scale genetic screening (first study part) via an online questionnaire.

    Measured: At the large-scale genetic screening

  19. Use of illegal drugs

    Self-reported use of illegal drugs is recorded during the large-scale genetic screening (first study part) via an online questionnaire.

    Measured: At the large-scale genetic screening

  20. Use of tobacco products

    Use of tobacco products is reported during the large-scale genetic screening (first study part) via an online questionnaire.

    Measured: At the large-scale genetic screening

  21. Subjective sleep quality

    Participants report about their subjective sleep quality during the large-scale genetic screening (first study part) via filling out the online questionnaire "Pittsburgh Sleep Quality Index" (high global PSQI score indicates poor sleep quality).

    Measured: At the large-scale genetic screening

  22. Daytime sleepiness

    Participants report about their daytime sleepiness during the large-scale genetic screening (first study part) via filling out the online questionnaire "Epworth Sleepiness Scale " (high ESS score indicates high daytime sleepiness).

    Measured: At the large-scale genetic screening

  23. Diurnal preference

    Participants report about their diurnal preference during the large-scale genetic screening (first study part) via filling out the online questionnaire "Munich Chronotype Questionnaire" (if the mid-sleep time on the MCTQ is earlier than 04:00, the participant is considered as preferential morning type, otherwise as preferential evening type).

    Measured: At the large-scale genetic screening

  24. Habitual bedtime

    Participants report about their subjective habitual bedtime (hh:mm) during the large-scale genetic screening (first study part) via filling out the online questionnaire "Pittsburgh Sleep Quality Index".

    Measured: At the large-scale genetic screening

  25. Habitual rise time

    Participants report about their subjective habitual rise time (hh:mm) during the large-scale genetic screening (first study part) via filling out the online questionnaire "Pittsburgh Sleep Quality Index".

    Measured: At the large-scale genetic screening

  26. Reported time to fall asleep

    Participants report about their subjective time to fall asleep (min) during the large-scale genetic screening (first study part) via filling out the online questionnaire "Pittsburgh Sleep Quality Index".

    Measured: At the large-scale genetic screening

  27. Reported sleep duration

    Participants report about their subjective sleep duration (h:mm) during the large-scale genetic screening (first study part) via filling out the online questionnaire "Pittsburgh Sleep Quality Index".

    Measured: At the large-scale genetic screening

  28. Positive and Negative Affect Schedule

    Participants report about positive and negative feelings (over the last 12 months) during the large-scale genetic screening (first study part) via filling out the online questionnaire "Positive and Negative Affect Schedule".

    Measured: At the large-scale genetic screening

  29. Nocturnal mentation

    Participants report about their nocturnal mentation during the large-scale genetic screening (first study part) via filling out online the "Dream Thought Questionnaire".

    Measured: At the large-scale genetic screening

  30. Depressive tendency

    Participants report about their depressive-like symptoms (experienced in the last 2 weeks) during the large-scale genetic screening (first study part) via filling out the online questionnaire "Beck Depression Index II (BDI-II)".

    Measured: At the large-scale genetic screening

  31. Mental suggestibility tendency

    Participants report about their mental suggestibility tendency during the large-scale genetic screening (first study part) via filling out the online questionnaire "Short Suggestibility Scale".

    Measured: At the large-scale genetic screening

  32. Schizotypal tendency

    Participants report about their schizotypal tendencies during the large-scale genetic screening (first study part) via filling out an online adaptation of the questionnaire "Magical Ideation Scale (MIS)".

    Measured: At the large-scale genetic screening

  33. ADHD tendency

    Participants report about their ADHD-like symptoms during the large-scale genetic screening (first study part) via filling out the online questionnaire "Adult ADHD Self-Report Scale v1.1 (ASRS)".

    Measured: At the large-scale genetic screening

  34. EEG power spectra during wakefulness

    Power spectra will be computed from artifact-free EEG data recorded during wakefulness. Spectral power (µV²/Hz) will be computed in standard frequency bands.

    Measured: Assessed on each of the four experimental nights, from pre- and post-sleep wake electroencephalographic recordings

  35. EEG power spectra during Rapid Eye Movement (REM) sleep

    Power spectra will be computed from artifact-free EEG data recorded during REM sleep. Spectral power (µV²/Hz) will be computed in standard frequency bands.

    Measured: 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

  36. Aperiodic component of the EEG power spectrum during NREM sleep

    The NREM sleep power spectra will be used to extract and parametrize the aperiodic component.

    Measured: 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

  37. Aperiodic component of the EEG power spectrum during REM sleep

    The REM sleep power spectra will be used to extract and parametrize the aperiodic component.

    Measured: 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

  38. Aperiodic component of the EEG power spectrum during wakefulness

    The wake power spectra will be used to extract and parametrize the aperiodic component.

    Measured: Assessed on each of the four experimental nights, from pre- and post-sleep wake electroencephalographic recordings

  39. Periodic component of the EEG power spectrum during NREM sleep

    Gaussian peaks detected in the NREM sleep power spectrum will be used to extract the periodic components, including center frequency, power, and bandwidth.

    Measured: 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

  40. Periodic component of the EEG power spectrum during REM sleep

    Gaussian peaks detected in the REM sleep power spectrum will be used to extract the periodic components, including center frequency, power, and bandwidth.

    Measured: 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.

  41. Periodic component of the EEG power spectrum during wakefulness

    Gaussian peaks detected in the wake power spectrum will be used to extract the periodic components, including center frequency, power, and bandwidth.

    Measured: Assessed on each of the four experimental nights, from pre- and post-sleep wake electroencephalographic recordings

  42. Sleep efficiency

    Sleep electroencephalographic data allow to extract sleep efficiency (%) ((total sleep time/time in bed) * 100)

    Measured: 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

  43. Sleep latency

    Sleep electroencephalographic data allow to extract sleep latency (time between lights-off and first occurrence of NREM sleep stage N2).

    Measured: 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.

  44. Wakefulness after sleep onset

    Sleep electroencephalographic data allow to extract WASO (min) (wakefulness after sleep onset).

    Measured: 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

  45. Time spent in the different sleep stages

    Sleep electroencelographic data allow to calculate the time (min) spent in each sleep substage (NREM1, NREM2, NREM3, REM).

    Measured: 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

  46. Neurocognitive performance as assessed in the sequential finger tapping task (FTT)

    The FTT is administered before and after sleep at each experimental night and provides a score reflecting procedural memory and learning performance.

    Measured: Assessed on each of the four experimental nights, pre- and post-sleep

  47. Neurocognitive performance as assessed in the visuospatial 2D Object Location Task (OLT)

    The OLT is administered before and after sleep at each experimental night and provides a score reflecting declarative memory and learning performance.

    Measured: Assessed on each of the four experimental nights, pre- and post-sleep

  48. Heart rate variability

    Heart rate variability is extracted from electrocardiographic recording during exposure and from polysomnographic overnight recordings.

    Measured: Assessed on each of the four experimental nights, from electrocardiographic recordings during pre-sleep exposure and polysomnographic overnight recordings

  49. Pupil size

    Pupil size variation is recorded during exposure.

    Measured: Assessed on each of the four experimental nights, from pupillometry recordings during pre-sleep exposure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2025
  2. Study start22 Oct 2024
  3. Primary completionJun 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06998368
Sponsor's protocol ID
5G-Cav1.2 Sleep
Acronym
5G Cav12 Sleep
Status last verified
May 2025
First submitted
23 Apr 2025
Last updated
31 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Any disclosure of information to individuals not directly involved in the study must be approved by the owner of the data.

Questions about this trial

What is this clinical trial studying?

A study testing Nimodipine Capsules and 5G RF-EMF in people with Mediation of 5G Effects on Sleep, run by Hans-Peter Landolt at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep spindle center frequency (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.

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