Welcome to the study: 5G-Cav1.2 Sleep

Welcome to the study: 5G-Cav1.2 Sleep

This study investigates the effects of 5G Radio-Frequency Electromagnetic Fields (RF-EMR) on sleep. Our main goal is detemining the potential acute effects of a standardized 5G RF-EMF exposure on sleep and cognitive function, and to test the causal role of the brain voltagegated CaV1.2 channels in the mediation of these effects. 
This study is conducted in two independent parts: 

•  1^st part: online questionnaire and saliva sample collection (via post) (visit 0)
• 2^nd part: sleep study (in person at Irchel campus) (visits 1-6)

Key information: 

• Participation duration: 0.5 hours for the first study part, 2 to 3 weeks for the second part. 
• Number of visits: as for the first study part, there will be no in person visit; for the second study part, 5 overnight stays and 1 1-hour visit in the sleep-lab (Irchel campus) are planned. 
• Study objectives: Investigate whether selective blockade of brain CaV1.2 channels attenuates or prevents the observed 5G RF-EMF (3.6 GHz) effects on sleep electrophysiology and cognitive function. 
• Participation to both parts of the study is voluntary and independent, and withdrawal from the study wihtout providing a reason is allowed. Our top priority is the protection of your health and data. 

Study goal

This study aims to link the 5G RF-EMF exposure to brain and sleep health by investigating the potential causal role of CaV1.2 channels. 

Study process

• Postal visit (visit 0): Upon completion of the online questionnaire (provided via e-mail), participants will receive by post the study material, including a copy of the signed informed consent, study information, and a kit for the saliva sample collection. Upon sample collection, they will be able to send it back via post. Participants who will be eligible to take part in the second study part will be contacted and asked if interested in the second study part. 
• Screening night (visit 1): this first visit includes verbal and written information about the study, signing of the informed consent, neurocognitive and neuropsychiatric testing, screening polysomnography (recording of high-density electroencephalogram, elctrooculogram, electromyogram, elctrocardiogram and non-invasive monitoring of other peripheral parameters) and completion of questionnaires. Further visits will be scheduled, and potential adverse events will be evaluated.
• Delivery of activity monitor and sleep-wake diary (visit 2): during this visit we will hand in and instruct participants about the activity monitor and sleep-wake diary, provide insturction about behavioral guidelines before experimental nichts and schedule further visits. 
• Experimental nights (visit 3-6): these nights will take place 6-9, 9-12, 12-15, 15-18 days respectively after the screening night. All of them will include a 5G active or sham exposure as well as the administration of nimodipine or placebo. An experimental polysomnography, high-density EEG recording during wake and non-invasive pupil size monitoring will be performed. Additionally, participants will fill in a questionnaire. Other procedures carried out during these visits are: 
  - pregnancy test (female participants only)
  - computerized neurocognitive and neuropsychiatric testing
  - determination of caffeine, alcohol and body temperature level. 

Main participation criteria

• For the first part of the study, participants must be adults in the age range of 20 to 40 years and must have German and/or English language skills (reading and writing)
• In order to be eligible for the second part of the study (screening and experimental nights), participants must be carriers of the T/C allele of the CACNA1C gene (SNP-ID: rs7304986), as determined in the first part of this study or during participation to our previous research (BASEC-ID: 2016-02049)

Participation in both parts of the study is voluntary and independent, and withdrawal from the study without providing a reason is allowed. Our top priority is the protection of participants' health and data. 

5G exposure

The 30-minute 5G RF-EMF exposure is comparable to a phone call in 5G mode: the signal intensity is below the internationally recommended limits for the Specific Absorption Rate (SAR), and, according to current knowledge, is considered harmless. 

Nimodipine

Nimodipine is a registered drug in Switzerland and Europe for the treatment of subarachnoid hemorrhage. Oral Nimodipine is usually well tolerated, and its main adverse reaction is imbalance in blood pressure, which will be measured at constant intervals during the study. The dose used in this trial is sub-clinical, which results in a minimal risk profile. 

Study location

The study is conducted at the University of Zurich, Campus Irchel, at the Institute of Pharmacology and Toxicology, where our sleep lab is located. 

The sleep lab offers a comfortable and quiet environment, designed like a regular bedroom to ensure a relaxed sleeping atmospere. 

Address

University of Zurich, Campus Irchel
Institute of Pharmacology and Toxicology
Winterthurerstrasse 190
CH-8057 Zürich

Contract information

For questions or to apply for participating in the study, please contract our study team:
Email: rachele.dangelo@pharma.uzh.ch 

What is a clinical study and why is it important?

A clinical study is a scientific investigation that examines new tests and treatments to evaluate their effects on human health. In this case, we aim to determine the effects that 5G exposure has on our sleep. 

What should I be aware of during the study? 

During the study, you must adhere to specific guidelines, such as restricted use of cell phone from the evening before the experimental night, adherence to regular bedtimes from 23:00 to 7:00, no sports or sauna visits the day of the experimental nights, no traveling with a time difference of more than 2 time zones, no shift work at night, no smoke, no alcohol, no daytime napping. Participating in other clinical studies at the same time is prohibited.

Participants are required to inform the principal investigators if their health condition changes, even if they want to withdraw from the study prematurely, or if they no longer meet one or more inclusion criteria.

To ensure accurate data collection, questionaires and responses during questionnaires/interviews should be completed truthfully. 

What are the risks for me?

This  study is classified in the risk category B, which means that risks associated with both interventions, as well as those relative to measurements and recordings, are minimal. 

Note that the dosage regimen is not recognized as standard (it is a lower, subclinical dose). 

The possible side-effect that can be expected is a blood pressure imbalance, which will be monitored at constant intervals during the study.

Can I withdraw from the study at any time?

Yes, you can withdraw from the study at any time without providing a reason. Your medical care will not be affected by this decision.

If you choose to withdraw, we kindly ask you to inform the study team so they can free up appointment slots and avoid concerns if you do not show up to the visit. 

Will I receive personal results from the study?

After the study concludes, you may receive a summary of the general results upon request. 

Personal results relevant to you health will also be shared with you if you agree. 

Is my participation compensated?

For the first part of the study (questionnaire and genotyping), one voucher of CHF 1'000.00 and four of CHF 250.00 will be raffled among all participants. 

For the second part, participants who complete all the study visits will be compensated with CHF 600.00. Participants interested in participating, but excluded, will receive CHF 50.00. In cas of no-shows or disregard of the agreements, the right to compensation will lapse.

In case of accident/illness or premature termination, the completed part of the study will be compensated (CHF 50.00 per night spent in the sleep laboratory). 

Travelling costs associated with the study will be reimbursed. 

What are the requirements for participation?

For the first part of the study: 

- Age between 20 and 40 years.
- German and/or English language skills (reading and writing).
- Signing an informed consent form.

For the second and third part of the study: 

- Participation in the first part of this study or on the previous one (BASEC-ID: 2016-002049).
- Carriers of the T/C allele of the CACNA1C gene (SNP-ID: rs7304986).
- If female, only if using hormonal contraception for the duration of the study (pill, three-month
  injection, hormonal implant, hormonal patch).
- Body mass index (BMI) between 17 and 26 kg/m².
- Moderate alcohol consumption (less than 5 alcoholic drinks/week).
- Moderate caffeine consumption (less than 3 caffeinated products/day).
- Signing an informed consent form. 

How often do I need to visit the sleep lab?

The first study part will take place fully remotely. In case you will be eligible and willing to participate in the second part of the study, you will visit the sleep lab 5 times for overnight stays and once for the delivery/instruction on the activity monitor and sleep-wake diary. 

Can I continue taking my regular medications during the study?

Some medications may conflict with the study. Before starting, the study team will discuss whether adjustments are necessary for your current medications. There is the possibility of it being an exclusion criterium. 

What happens if I become ill during the study?

If you become ill during the study or new health issues arise, you should immediately notify the study team. They will determine whether you can continue participating in the study. 

Will my health insurance be charged for participation?

No, all costs associated with the study are covered by the study sponsor. Neither you nor your health insurance will incur any additional expenses. 

What measures are taken to protect my privacy?

Your personal data will be treated with strict confidentiality. All collected data is anonymized and encrypted to protect your identity. Only authorized personnel have access to you data, and they are bound by confidentiality obligations. 

What happens to the study results?

The study results will be scientifically analyzed and may be published in academic journals. Your identity will remain protected, as only anonymized data will be used. The findings could contribute to understanding the effects of 5G on sleep and health. 

How long does participation take?

First study part: 0.5 hours (remote participation). 

Second study part: 5 overnight in-person visits of 12 hours each and 1 1-hour appointment for the activity monitor and sleep-wake diary delivery, to be carried out in the time frame of 2 to 3 weeks. The in-person visits will be individually scheduled and agreed on with participants.