The Grounded Brain: How Sleeping Grounded Affects Memory and Perceptions

Phase

N/A

Condition

Mild Cognitive Impairment

Inflammation

Dementia

Treatment

N/A

Clinical Study ID

NCT05050812

PFJ001

Ages > 55
All Genders

Study Summary

Grounding (Earthing) refers to the practice of contacting the Earth or a properly installed grounding mat with the body. Previous studies on grounding have shown positive effects body-wide inflammation, acute and chronic pain, and immune system response. Prior studies on the inflammatory process of mild cognitive impairment due to Alzheimer's disease, Alzheimer's disease, and some other dementias have shown connections between immune system dysregulation, inflammatory markers, and severe disease progression. Finding ways to mitigate or turn off the inflammatory response is key to treating mild cognitive impairment due to Alzheimer's disease. The purpose of this study is to evaluate the effects of sleeping grounded on cognition and personal perceptions in participants with a diagnosis of mild cognitive impairment due to Alzheimer's disease as evidenced by a battery of assessments using Cogstate's Cognitive Brief Battery and a qualitative questionnaire. We hypothesize that assessment scores will improve with grounding and that perceptions will positively correlate with an increase in scores. Modulation of risk factors like glucocorticoid resistance, SCI, and immune system dysfunction through grounding may lead to an accessible, natural technique for neurodegenerative disease prevention or treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

All approved participants must

Be at least 55 years of age; all genders and ethnicities;
Have English as their primary language or be able to speak, read, and writeEnglish fluently; As this is a vulnerable population, this investigator must beable to evaluate understanding and cannot reliably do that with someone who isnot fluent in English;
Have a current diagnosis of mild cognitive impairment due to Alzheimer's diseasemade by a medical doctor;
Be able to spend at least 6 hours per 24-hour period sleeping or resting on thegrounded mat;
Be able to legally consent to participating in this study;
Agree to allow the researcher to come into their home to setup the equipment andadminister the tests;
Be able to see well enough to use a laptop to complete electronic testing;
Be alert and oriented X 4 based on initial verbal screening and in-person visits;
Reside in or around the Greater Austin, Texas, area/Central Texas area;
Sleep in a dwelling that is grounded.

Exclusion

Exclusion Criteria:

All approved participants must

Not have a diagnosis or conversion to AD or any other type of memory disorderbefore or during the study period including but not limited to dementia, Lewybody disease, Creutzfeldt-Jakob disease, Parkinson's disease, Huntington'sdisease, vascular cognitive impairment, frontotemporal dementias, primaryprogressive aphasia, autoimmune encephalopathy, and normal pressurehydrocephalus;
Not have a diagnosis of stable MCI;
Not have any prior diagnosis of traumatic brain injury;
Not have any history of grounding consistently for more than 60 minutes/day inthe past year. This includes natural methods and the use of any groundingdevices;
Not have any in-the-moment assessment that leads the investigator to believe thatthe participant is not fully aware or does not understand what is being asked ofthem. Again, this is a vulnerable population, and I will exclude or cut anyparticipant who shows signs of confusion;
Not be taking or have taken in the previous 30 days any of the followingmedications:
daily anti-inflammatories, prescription or over the counter;
blood pressure medications (anti-hypertensives);
blood thinners (anti-coagulants); e. glucose control medications; f. thyroid medications; g. anti-convulsivemedications (no matter the diagnosis); h. any type of monoclonal antibody; i. anytype of immunosuppressive, including steroids; j. any type of immunomodulator.
Inability to answer the questions in the initial screening interview;
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 thosethings are generally sought after, there could be dire consequences if a participant is ona medication to correct any of those conditions, so in the interest of safety, exclusionbased on certain medications is necessary. In that same vein, if any participant must begina medication during the study period, that participant will be disqualified in the interestof safety.

Study Design

September 01, 2021

December 31, 2021

Study Description

Grounding (Earthing) refers to the practice of contacting the Earth or a properly installed grounding mat with the body. Previous studies on grounding have shown positive effects on diurnal cortisol regulation, systemic chronic inflammation (SCI), immune system response, acute and chronic pain, mood, vagal tone, blood viscosity, blood flow, recovery from muscle strain and damage, and prevention or mitigation of chronic inflammatory and autoimmune diseases. Prior studies on the inflammatory process of mild cognitive impairment due to Alzheimer's disease, Alzheimer's disease, and some other dementias have shown connections between immune system dysregulation, inflammatory markers, and severe disease progression. The purpose of this study is to evaluate the effects of sleeping grounded on cognition and personal perceptions in participants with a diagnosis of mild cognitive impairment due to Alzheimer's disease (MCI/AD) as evidenced by a battery of tests using the Cogstate platform's Cognitive Brief Battery (CBB) and a qualitative questionnaire to detect any correlations to the participant's perceptions of sleep quality, mood, pain, and overall well-being.

This study will both fulfill the requirement for a Bachelor of Science in Psychology and lay the foundation for further research into grounding and neurodegenerative diseases. My senior research project methodology is a mixed methods research design with a triangulation convergence, since I'll be concurrently collecting, analyzing, and evaluating the results of the quantitative and qualitative measurements before comparing, integrating, and interpreting the outcomes.

I have three hypotheses. First, I hypothesize that sleeping while grounded will result in improved scores on the Cogstate battery of tests given at baseline and weekly for three weeks. Second, I hypothesize that sleeping while grounded will result in positive perceptions regarding sleep quality, mood, pain, and overall well-being. Finally, I hypothesize that improved Cogstate scores will positively correlate with perceptions of sleep quality, mood, and overall well-being and negatively correlate with pain. The independent variable is the intervention (grounded sleeping mat), and the dependent variables are the three measurements of cognition (memory, working memory, and processing speed) and the qualitative questionnaire to evaluate how the participants feel about their sleep quality, mood, pain, and overall well-being.

The target population for this study will be adults aged 55 and up (N=8) with a current diagnosis of MCI/AD who meet the inclusion and exclusion criteria. I will employ a mixed methods research design that includes statistical analysis of empirical data and a qualitative questionnaire. I will use a triangulation convergence, since I'll be concurrently collecting, analyzing, and evaluating the results of the quantitative and qualitative measurements before comparing, integrating, and interpreting the outcomes. First, I will look at the percentage of change in each testing area from week to week and calculate the statistical significance (p < .01) of any changes. Second, I will calculate the mean of all the test scores per day (baseline and weekly X 3) to obtain a general cognition score which I will also use to calculate statistical significance (p < .01) of changes over time. Third, I will perform a simple linear regression analysis to determine if a correlation exists between the intervention and the cognition scores after baseline. Finally, I will perform an analysis of the qualitative questionnaire using in vivo coding to determine if any correlations exist between the cognition scores and personal perceptions. For this study, I will interpret the results based on changes in test scores over time, changes in general cognition scores over time, and positive/negative correlations of the personal perceptions and cognition scores.

Each participant will receive an Earthing Elite™ sleep mat kit which they get to keep. The sleeping mat will be installed wherever the participant sleeps (bed or recliner), and I will ensure that the mat is properly attached to the grounding plug and confirm grounding using a multimeter with two terminal leads, a cord with alligator clips on both ends, an Earthing coil cord, and an outlet checker. This procedure will show body voltage prior to grounding and while grounding to confirm that the setup is working and that body voltage has been neutralized. I will return for repeat assessments after one week, two weeks, and three weeks at which time I will verify that the system is still working properly.

All computerized testing will consist of the following assessments on the Cogstate platform:

Detection test (psychomotor function); 2) Identification test (attention); 3) One Card Learning test (visual learning); and 4) One Back test (working memory). The personal perceptions qualitative questionnaire will consist of several open-ended and scaled questions designed to assess how the participants perceive various subjective areas such as sleep quality, pain, mood, and overall well-being. Each participant will complete the questionnaire first before completing the computerized cognition assessments.

Modulation of risk factors like glucocorticoid resistance, SCI, and immune system dysfunction through grounding may lead to an accessible, natural technique for neurodegenerative disease prevention or treatment.