Welcome!
We know you might have questions about our research study.
Stress is a normal human reaction in life when faced with daily challenges and can involve both physiological and psychological responses. While stress responses are normal and can be healthy, prolonged periods of stress can lead to negative health consequences.
Noninvasive technology, such as patches, offers users the potential for health and wellness benefits without stimulants entering the body, given its absence of ingredients. The Lifewave Nirvana patch has the potential to improve stress and mood using photo-biomodulation technology.
Here’s what you need to know about participating. This page provides a summary. For full details about your rights, potential risks, and study procedures, please refer to the complete Participant Information and Consent Form.
The following steps are required to proceed:
1.Please click on the video Screen Below to Watch the Introduction to the stress and mood improvment study
In this video, you will find the purpose of this study, the study design, risks and benefits and what is expected from the participant and if you decide to participate. After listening to this recording, please read the informed consent and assent forms and the Frequently Asked Questions.
Stress and Mood Improvement Introduction Video
2.Please Review the ICF Form here.
Please review the Informed Consent Form. You do not need to sign this copy but will be required to sign an electronic copy when you decide to join the study and before screening can begin.
3. Frequently Asked Questions
What is the purpose of this clinical study?
This clinical study is called “A randomized, virtual, triple-blind, placebo-controlled, parallel clinical trial to investigate the efficacy and safety of the LifeWave Nirvana patch in healthy adults with moderate stress”
The objective of this study is to investigate the efficacy and safety of the LifeWave Nirvana patch in healthy adults with moderate stress.
What does "randomized" and "triple-blind" mean?
- Randomized means that you will be assigned by chance, like flipping a coin, to a study group (either the LifeWave Nirvana group or the placebo group). You will receive the study products based on the group you are assigned to.
- This is a triple-blind study, so neither you, the study staff, nor the researchers analyzing the data will know which group you have been assigned to or which product you will receive (LifeWave Nirvana patch or placebo patch).
What is the study product? What is in it?
LifeWave Nirvana patch
LifeWave Nirvana patch is a wearable non-transdermal patch that does not deliver any active ingredients into the body. The patch is made of water, stabilized oxygen, stereoisomers of organic sugars and stereoisomers of amino acids.
The mix of these materials is placed in a sealed pouch made from medical-grade polyethylene plastic. One side of the patch has a hypoallergenic, medical-grade adhesive that allows it to stick to your skin or clothing.
The LifeWave patch uses a technology called photobiomodulation (PBM), where the body’s own natural heat (infrared energy) activates the patch’s materials to stimulate biological responses when placed on the skin surface at acupuncture points. This is a non-invasive approach and does not introduce any chemicals or drugs into the body.
Placebo
A placebo is a patch that looks like the LifeWave Nirvana patch but has no active technology. The ingredients in the placebo patch include laminate film, non-woven material, adhesive medical tape with backing, distilled water
Are there any side effects?
It is possible that you could have problems or side effects from the study product that nobody knows about yet. Potential side-effects of using the study product may include:
- Allergic skin reactions or sensitivity to the adhesive including: Itching, redness, irritation of the skin.
Please ensure proper skin cleaning and drying before applying the patch. If you experience redness or skin irritation around the area where the patch is applied, remove it immediately and inform the study staff. If symptoms last longer than 2-3 days of not using the patch, seek medical attention and inform the study staff.
How should I wear the patch during the study
- Beginning on Day 1 (the day after you confirm receipt of the study product), you will apply the patch to the back of the neck or directly below the bellybutton on clean dry skin first thing each morning and remove after 12 hours or before going to bed. Make sure your skin is clean and dry before applying the patch. If the patch gets wet after it is applied, it will continue to work.
- Please maintain the same site of application and same time of day the patch will be applied and removed for the entire duration of the study.
- If the patch falls off over the course of the 12 hours, please clean and dry the application site and reapply a new patch for the remainder of the 12-hour daily wear.
- If you forget to apply the patch on one day, apply it as soon as you remember and wear it for 12 hours or the remainder of the day ensuring you take it off before you go to sleep (even if the patch has not been applied on for the full 12 hours).
- If you forget to remove the patch and wear it longer than approximately 12 hours, please remove it as soon as you remember
- You will keep all used and unused patches and have them available for counting during your virtual visits
How/when can I find out if I got the investigational product or the placebo?
- This study is designed to be triple-blinded. That means that during the study, neither you nor the study staff will know if you are taking the study product or placebo.
- If you are interested in learning if you received the product or placebo, we can let you know at a later date, when all participants have completed the study and statistical analysis of the data has been completed.
- If needed for your safety, the study staff can find out this information.
How long will the study last?
- Once you receive your study product your participation will continue for approximately 28 days.
- You will have two study visits
Do I have to come into the clinic for any assessments?
- No! This study is virtual.
- You will complete two virtual study visits, approximately 14 and 28 days after you begin wearing the study product. These visits will take place through video conference calls with clinic staff
- If you prefer, you can attend your visits in person.
Who/how do I contact if I have any questions?
If you have any questions, you can reach out to our clinic at the following email address: clinic@kgkscience.com
What is the compensation for participating?
For your time and participation in the study, you will be compensated a total of $200, if you complete the entire study and all associated requirements.
How and when will I receive my compensation for participation?
- You will receive your compensation on a ClinCard. You will receive the Clincard with the study product at the start of the study.
- Your ClinCard is a prepaid credit card that can be used anywhere that accepts Mastercard, or the funds can be withdrawn from an ATM (ATM fees apply). Processing times may apply before funds become available on your ClinCard.
Is my participation confidential?
- Yes! KGK Science research staff will keep all of your personal medical information confidential to the extent required by law. You will not be identified in any publication that may result from the study.