Clinical trial NCT05050812: The Grounded Brain: How Sleeping Grounded Affects Memory and Perceptions
Official title: The Grounded Brain: How Sleeping Grounded (Earthing) Affects Cognition and Personal Perceptions in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (MCI/AD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Chronic Inflammation
Keywords: Earthing
systemic chronic inflammation
grounding
SCI
immune system
sleep quality
mood
pain
well-being
mild cognitive impairment due to Alzheimer's disease
MCI
glucocorticoid resistance
neurodegenerative
Cogstate Cognitive Brief Battery
Cogstate CBB
Lead sponsor: California Institute of Integral Studies
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 8
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An interventional, single-group method that lacks random assignment and has no control group but does provide baseline and post-intervention testing.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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: 1) 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.

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.

Primary outcomes:
measure: Baseline Psychomotor Function Score
timeFrame: Baseline
measure: Week 1 Psychomotor Function Score
timeFrame: Week 1
measure: Week 2 Psychomotor Function Score
timeFrame: Week 2
measure: Week 3 Psychomotor Function Score
timeFrame: Week 3
measure: Change from Baseline to Week 3 Psychomotor Function Score
timeFrame: Change from baseline to week 3
measure: Baseline Attention Score
timeFrame: Baseline
measure: Week 1 Attention Score
timeFrame: Week 1
measure: Week 2 Attention Score
timeFrame: Week 2
measure: Week 3 Attention Score
timeFrame: Week 3
measure: Change from Baseline to Week 3 Attention Score
timeFrame: Baseline to week 4
measure: Baseline Visual Learning Score
timeFrame: Baseline
measure: Week 1 Visual Learning Score
timeFrame: Week 1
measure: Week 2 Visual Learning Score
timeFrame: Week 2
measure: Week 3 Visual Learning Score
timeFrame: Week 3
measure: Change from Baseline to Week 3 Visual Learning Score
timeFrame: Baseline to Week 3
measure: Baseline Working Memory Score
timeFrame: Baseline
measure: Week 1 Working Memory Score
timeFrame: Week 1
measure: Week 2 Working Memory Score
timeFrame: Week 2
measure: Week 3 Working Memory Score
timeFrame: Week 3
measure: Change from Baseline to Week 3 Working Memory Score
timeFrame: Baseline and Week 3
measure: Baseline Sleep Quality Score
timeFrame: Baseline
measure: Week 1 Sleep Quality Score
timeFrame: Week 1
measure: Week 2 Sleep Quality Score
timeFrame: Week 2
measure: Week 3 Sleep Quality Score
timeFrame: Week 3
measure: Change from Baseline to Week 3 Sleep Quality Score
timeFrame: Week 3
measure: Baseline Pain Score
timeFrame: Baseline
measure: Week 1 Pain Score
timeFrame: Week 1
measure: Week 2 Pain Score
timeFrame: Week 2
measure: Week 3 Pain Score
timeFrame: Week 3
measure: Change from Baseline to Week 3 Pain Score
timeFrame: Baseline to Week 3
measure: Baseline Mood Score
timeFrame: Baseline
measure: Week 1 Mood Score
timeFrame: Week 1
measure: Week 2 Mood Score
timeFrame: Week 2
measure: Week 3 Mood Score
timeFrame: Week 3
measure: Change from Baseline to Week 3 Mood Score
timeFrame: Baseline to Week 3
measure: Baseline Overall Well-Being Score
timeFrame: Baseline
measure: Week 1 Overall Well-Being Score
timeFrame: Week 1
measure: Week 2 Overall Well-Being Score
timeFrame: Week 2
measure: Week 3 Overall Well-Being Score
timeFrame: Week 3
measure: Change from Baseline to Week 3 Overall Well-Being Score
timeFrame: Baseline to Week 3
Secondary outcomes:
measure: Correlation of Change in Psychomotor Function Score and Sleep Quality Score from Baseline to Week 3
timeFrame: Baseline to Week 3
measure: Correlation of Change in Psychomotor Function Score and Pain Score from Baseline to Week 3
timeFrame: Baseline to Week 3
measure: Correlation of Change in Psychomotor Function Score and Mood Score from Baseline to Week 3
timeFrame: Baseline to Week 3
measure: Correlation of Change in Psychomotor Function Score and Overall Well-Being Score from Baseline to Week 3
timeFrame: Baseline to Week 3
measure: Correlation of Change in Attention Score and Sleep Quality Score from Baseline to Week 3
timeFrame: Baseline to Week 3
measure: Correlation of Change in Attention Score and Pain Score from Baseline to Week 3
timeFrame: Baseline to Week 3
measure: Correlation of Change in Attention Score and Mood Score from Baseline to Week 3
timeFrame: Baseline to Week 3
measure: Correlation of Change in Attention Score and Overall Well-Being Score from Baseline to Week 3
timeFrame: Baseline to Week 3
measure: Correlation of Change in Visual Learning Score and Sleep Quality Score from Baseline to Week 3
timeFrame: Baseline to Week 3
measure: Correlation of Change in Visual Learning Score and Pain Score from Baseline to Week 3
timeFrame: Baseline to Week 3
measure: Correlation of Change in Visual Learning Score and Mood Score from Baseline to Week 3
timeFrame: Baseline to Week 3
measure: Correlation of Change in Visual Learning Score and Overall Well-Being Score from Baseline to Week 3
timeFrame: Baseline to Week 3
measure: Correlation of Change in Working Memory Score and Sleep Quality Score from Baseline to Week 3
timeFrame: Baseline to Week 3
measure: Correlation of Change in Working Memory Score and Pain Score from Baseline to Week 3
timeFrame: Baseline to Week 3
measure: Correlation of Change in Working Memory Score and Mood Score from Baseline to Week 3
timeFrame: Baseline to Week 3
measure: Correlation of Change in Working Memory Score and Overall Well-Being Score from Baseline to Week 3
timeFrame: Baseline to Week 3
Other outcomes:
Locations:
Study officials:
affiliation: California Institute of Integral Studies
name: Patrice F Jones, CPC
role: PRINCIPAL_INVESTIGATOR
affiliation: California Institute of Integral Studies
name: Anne Huffman, PhD
role: STUDY_DIRECTOR
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