A Causal Role for Voltage-gated Cav1.2 Calcium Channels in Mediating 5G FR1 Effects on Sleep-associated Brain Health in Humans
NCT ID: NCT06998368
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-10-22
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
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.
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm2
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.
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.
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.
Arm1
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.
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.
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.
Arm3
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.
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.
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.
Arm4
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.
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.
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.
Arm6
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.
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.
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.
Arm7
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.
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.
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.
Arm8
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.
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.
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.
Arm9
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.
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.
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.
Arm10
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.
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.
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.
Arm11
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.
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.
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.
Arm12
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.
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.
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.
Arm5
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.
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.
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.
Arm13
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.
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.
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.
Arm14
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.
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.
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.
Arm15
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.
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.
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.
Arm16
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.
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.
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.
Arm17
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.
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.
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.
Arm18
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.
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.
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.
Arm19
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.
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.
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.
Arm20
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.
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.
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.
Arm21
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.
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.
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.
Arm22
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.
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.
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.
Arm23
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.
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.
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.
Arm24
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
40 Years
ALL
Yes
Sponsors
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Federal Office for the Environment, Switzerland
OTHER_GOV
Hans-Peter Landolt
OTHER
Responsible Party
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Hans-Peter Landolt
Prof. Dr. sc. nat.
Locations
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University of Zurich, Institute of Pharmacology and Toxicology
Zurich, Canton of Zurich, Switzerland
Countries
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Facility Contacts
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Related Links
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Pre-print of our previous research project, providing the background for the current study
Other Identifiers
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5G-Cav1.2 Sleep
Identifier Type: -
Identifier Source: org_study_id
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