Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
NCT ID:
NCT05050812
Eligibility Criteria:
Inclusion Criteria:
* All approved participants must
1. Be at least 55 years of age; all genders and ethnicities;
2. Have English as their primary language or be able to speak, read, and write English fluently; As this is a vulnerable population, this investigator must be able to evaluate understanding and cannot reliably do that with someone who is not fluent in English;
3. Have a current diagnosis of mild cognitive impairment due to Alzheimer's disease made by a medical doctor;
4. Be able to spend at least 6 hours per 24-hour period sleeping or resting on the grounded mat;
5. Be able to legally consent to participating in this study;
6. Agree to allow the researcher to come into their home to setup the equipment and administer the tests;
7. Be able to see well enough to use a laptop to complete electronic testing;
8. Be alert and oriented X 4 based on initial verbal screening and in-person visits;
9. Reside in or around the Greater Austin, Texas, area/Central Texas area;
10. Sleep in a dwelling that is grounded.
Exclusion Criteria:
* All approved participants must
1. Not have a diagnosis or conversion to AD or any other type of memory disorder before or during the study period including but not limited to dementia, Lewy body disease, Creutzfeldt-Jakob disease, Parkinson's disease, Huntington's disease, vascular cognitive impairment, frontotemporal dementias, primary progressive aphasia, autoimmune encephalopathy, and normal pressure hydrocephalus;
2. Not have a diagnosis of stable MCI;
3. Not have any prior diagnosis of traumatic brain injury;
4. Not have any history of grounding consistently for more than 60 minutes/day in the past year. This includes natural methods and the use of any grounding devices;
5. Not have any in-the-moment assessment that leads the investigator to believe that the participant is not fully aware or does not understand what is being asked of them. Again, this is a vulnerable population, and I will exclude or cut any participant who shows signs of confusion;
6. Not be taking or have taken in the previous 30 days any of the following medications:
1. daily anti-inflammatories, prescription or over the counter;
2. blood pressure medications (anti-hypertensives);
3. blood thinners (anti-coagulants);
e. glucose control medications; f. thyroid medications; g. anti-convulsive medications (no matter the diagnosis); h. any type of monoclonal antibody; i. any type of immunosuppressive, including steroids; j. any type of immunomodulator.
7. Inability to answer the questions in the initial screening interview;
8. Inability to follow instructions.
A Note About Medications and Grounding:
Earthing has been proven to reduce inflammation, thin the blood, lower blood pressure, lower and better regulate glucose levels, and improve thyroid function. While all those things are generally sought after, there could be dire consequences if a participant is on a medication to correct any of those conditions, so in the interest of safety, exclusion based on certain medications is necessary. In that same vein, if any participant must begin a medication during the study period, that participant will be disqualified in the interest of safety.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT05050812
Study Brief:
Protocol Section:
NCT05050812