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New treatment option for Mediation of 5G Effects on Sleep
Official title A Causal Role for Voltage-gated Cav1.2 Calcium Channels in Mediating 5G FR1 Effects on Sleep-associated Brain Health in Humans
ClinicalTrials.gov ID: NCT06998368
What this study is testing
What is Nimodipine Capsules?
Nimodipine Capsules is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for mediation of 5g effects on sleep.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 40. Healthy volunteers may be eligible.
You may be able to join if
- 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)
You likely can't join if
- 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 \ 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...
See the full eligibility criteria
- For the first part of the study (genotyping and questionnaires):
- Age: 20-40 years old.
- German and/or English language skills (reading and writing)
- Informed Consent as documented by signature For the second and third party of the study:
- Completion of the first part of the present study or of the precursor study (BASEC-ID: 2016-02049)
- CACNA1C rs7304986 T/C allele-carrier
- Male gender
- Female gender if using hormonal contraception for the duration of the study (e.g., pill as combination/single preparation, three-month injection, hormonal IUD, hormonal implant, hormonal patch)
- Right-handedness
- Body Mass Index (BMI): BMI comprised between 17.0 kg/m2 and 26.0 kg/m2
- Moderate alcohol consumption (less than 5 reported alcoholic drinks per week)
- Moderate caffeine consumption (less than 3 reported caffeinated beverage or food products per day such as cola, coffee, energy drinks, green and black tea, chocolate)
- Informed Consent as documented by signature.
- 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 \ 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Zurich, Canton of Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zurich, Canton of Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.