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| Name | Class |
|---|---|
| Federal Office for the Environment, Switzerland | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the large-scale genetic screening |
| Age of Participants |
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Inclusion Criteria:
For the first part of the study (genotyping and questionnaires):
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
Exclusion Criteria:
For the second and third party of the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Zurich, Institute of Pharmacology and Toxicology | Recruiting | Zurich | Canton of Zurich | 8057 | Switzerland |
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| Label | URL |
|---|---|
| Pre-print of our previous research project, providing the background for the current study | View source |
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Any disclosure of information to individuals not directly involved in the study must be approved by the owner of the data.
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| ID | Term |
|---|---|
| D009553 | Nimodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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:
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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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.
| At the large-scale genetic screening |
| Pregnancy status | Female participants report current pregnancy status during the large-scale genetic screening (first study part) via an online questionnaire. | At the large-scale genetic screening |
| 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. | 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 | Sleep electroencephalographic data allow to extract total sleep time (min) (total amount of time spent asleep) | 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) | The PVT is administered before and after sleep at each experimental night and provides a score reflecting sustained or vigilant attention performance. | Assessed on each of the four experimental nights, pre- and post-sleep |
| Heart rate | Heart rate (bpm) is extracted from electrocardiographic recording during exposure and from polysomnographic overnight recordings | Assessed on each of the four experimental nights, from electrocardiographic recordings during pre-sleep exposure and polysomnographic overnight recordings |
| 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. | At the large-scale genetic screening |
| 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. | At the large-scale genetic screening |
| 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. | At the large-scale genetic screening |
| 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. | At the large-scale genetic screening |
| 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. | At the large-scale genetic screening |
| 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. | At the large-scale genetic screening |
| 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). | At the large-scale genetic screening |
| 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. | At the large-scale genetic screening |
| Comorbidities | Participants self-report the presence of comorbidities during the large-scale genetic screening (first study part) via an online questionnaire. | At the large-scale genetic screening |
| 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. | At the large-scale genetic screening |
| Use of medications | Self-reported use of medication is recorded during the large-scale genetic screening (first study part) via an online questionnaire. | At the large-scale genetic screening |
| 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. | At the large-scale genetic screening |
| Use of tobacco products | Use of tobacco products is reported during the large-scale genetic screening (first study part) via an online questionnaire. | At the large-scale genetic screening |
| 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). | At the large-scale genetic screening |
| 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). | At the large-scale genetic screening |
| 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). | At the large-scale genetic screening |
| 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". | At the large-scale genetic screening |
| 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". | At the large-scale genetic screening |
| 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". | At the large-scale genetic screening |
| 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". | At the large-scale genetic screening |
| 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". | At the large-scale genetic screening |
| 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". | At the large-scale genetic screening |
| 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)". | At the large-scale genetic screening |
| 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". | At the large-scale genetic screening |
| 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)". | At the large-scale genetic screening |
| 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)". | At the large-scale genetic screening |
| 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. | Assessed on each of the four experimental nights, from pre- and post-sleep wake electroencephalographic recordings |
| 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. | 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 |
| 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. | 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 |
| 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. | 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 |
| Aperiodic component of the EEG power spectrum during wakefulness | The wake power spectra will be used to extract and parametrize the aperiodic component. | Assessed on each of the four experimental nights, from pre- and post-sleep wake electroencephalographic recordings |
| 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. | 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 |
| 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. | 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. |
| 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. | Assessed on each of the four experimental nights, from pre- and post-sleep wake electroencephalographic recordings |
| Sleep efficiency | Sleep electroencephalographic data allow to extract sleep efficiency (%) ((total sleep time/time in bed) * 100) | 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 |
| Sleep latency | Sleep electroencephalographic data allow to extract sleep latency (time between lights-off and first occurrence of NREM sleep stage N2). | 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. |
| Wakefulness after sleep onset | Sleep electroencephalographic data allow to extract WASO (min) (wakefulness after sleep onset). | 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 |
| 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). | 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 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. | Assessed on each of the four experimental nights, pre- and post-sleep |
| 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. | Assessed on each of the four experimental nights, pre- and post-sleep |
| Heart rate variability | Heart rate variability is extracted from electrocardiographic recording during exposure and from polysomnographic overnight recordings. | Assessed on each of the four experimental nights, from electrocardiographic recordings during pre-sleep exposure and polysomnographic overnight recordings |
| Pupil size | Pupil size variation is recorded during exposure. | Assessed on each of the four experimental nights, from pupillometry recordings during pre-sleep exposure. |
| D009539 |
| Nicotinic Acids |