The Grounded Brain: How Sleeping Grounded Affects Memory and Perceptions

NCT05050812 | Unknown

• 1 other identifier: PFJ001
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (40)

• Baseline Psychomotor Function Score

  In this simple reaction time Detection test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up (revealing a Joker card - this same card is used throughout the test). The subject is asked to press the "YES" button as soon as the card turns face-up. Assessed at baseline then weekly for three weeks.

  Baseline

• Week 1 Psychomotor Function Score

  In this simple reaction time Detection test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up (revealing a Joker card - this same card is used throughout the test). The subject is asked to press the "YES" button as soon as the card turns face-up. Assessed at baseline then weekly for three weeks.

  Week 1

• Week 2 Psychomotor Function Score

  In this simple reaction time Detection test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up (revealing a Joker card - this same card is used throughout the test). The subject is asked to press the "YES" button as soon as the card turns face-up. Assessed at baseline then weekly for three weeks.

  Week 2

• Week 3 Psychomotor Function Score

  In this simple reaction time Detection test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up (revealing a Joker card - this same card is used throughout the test). The subject is asked to press the "YES" button as soon as the card turns face-up. Assessed at baseline then weekly for three weeks.

  Week 3

• Change from Baseline to Week 3 Psychomotor Function Score

  In this simple reaction time Detection test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up (revealing a Joker card - this same card is used throughout the test). The subject is asked to press the "YES" button as soon as the card turns face-up. Assessed at baseline then weekly for three weeks. Change = (Week 3 Psychomotor Function Score - Baseline Psychomotor Function Score).

  Change from baseline to week 3

• Baseline Attention Score

  In this choice reaction time Identification test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. Either a red Joker card or black Joker card will be revealed. As soon as the card turns face-up, the subject decides whether the card displayed is red. If the card is red, the subject should press the "YES" button, if it is not red, they should press "NO". Assessed at baseline then weekly for three weeks.

  Baseline

• Week 1 Attention Score

  In this choice reaction time Identification test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. Either a red Joker card or black Joker card will be revealed. As soon as the card turns face-up, the subject decides whether the card displayed is red. If the card is red, the subject should press the "YES" button, if it is not red, they should press "NO". Assessed at baseline then weekly for three weeks.

  Week 1

• Week 2 Attention Score

  In this choice reaction time Identification test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. Either a red Joker card or black Joker card will be revealed. As soon as the card turns face-up, the subject decides whether the card displayed is red. If the card is red, the subject should press the "YES" button, if it is not red, they should press "NO". Assessed at baseline then weekly for three weeks.

  Week 2

• Week 3 Attention Score

  In this choice reaction time Identification test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. Either a red Joker card or black Joker card will be revealed. As soon as the card turns face-up, the subject decides whether the card displayed is red. If the card is red, the subject should press the "YES" button, if it is not red, they should press "NO". Assessed at baseline then weekly for three weeks.

  Week 3

• Change from Baseline to Week 3 Attention Score

  In this choice reaction time Identification test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. Either a red Joker card or black Joker card will be revealed. As soon as the card turns face-up, the subject decides whether the card displayed is red. If the card is red, the subject should press the "YES" button, if it is not red, they should press "NO". Assessed at baseline then weekly for three weeks. Change = (Week 3 Attention Score - Baseline Attention Score).

  Baseline to week 4

• Baseline Visual Learning Score

  In this pattern separation One Card Learning test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card has been seen before in the test. The subject should press the "YES" button if they have seen the card before in the test, or "NO" if they have not. Assessed at baseline then weekly for three weeks.

  Baseline

• Week 1 Visual Learning Score

  In this pattern separation One Card Learning test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card has been seen before in the test. The subject should press the "YES" button if they have seen the card before in the test, or "NO" if they have not. Assessed at baseline then weekly for three weeks.

  Week 1

• Week 2 Visual Learning Score

  In this pattern separation One Card Learning test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card has been seen before in the test. The subject should press the "YES" button if they have seen the card before in the test, or "NO" if they have not. Assessed at baseline then weekly for three weeks.

  Week 2

• Week 3 Visual Learning Score

  In this pattern separation One Card Learning test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card has been seen before in the test. The subject should press the "YES" button if they have seen the card before in the test, or "NO" if they have not. Assessed at baseline then weekly for three weeks.

  Week 3

• Change from Baseline to Week 3 Visual Learning Score

  In this pattern separation One Card Learning test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card has been seen before in the test. The subject should press the "YES" button if they have seen the card before in the test, or "NO" if they have not. Assessed at baseline then weekly for three weeks. Change = (Week 3 Visual Learning Score - Baseline Visual Learning Score).

  Baseline to Week 3

• Baseline Working Memory Score

  In this N-back One Back test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card is the same as the previous card. The subject should press the "YES" button if the current card is the same as the one presented immediately before it, or "NO" if it is not the same. Assessed at baseline and weekly for three weeks.

  Baseline

• Week 1 Working Memory Score

  In this N-back One Back test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card is the same as the previous card. The subject should press the "YES" button if the current card is the same as the one presented immediately before it, or "NO" if it is not the same. Assessed at baseline and weekly for three weeks.

  Week 1

• Week 2 Working Memory Score

  In this N-back One Back test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card is the same as the previous card. The subject should press the "YES" button if the current card is the same as the one presented immediately before it, or "NO" if it is not the same. Assessed at baseline and weekly for three weeks.

  Week 2

• Week 3 Working Memory Score

  In this N-back One Back test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card is the same as the previous card. The subject should press the "YES" button if the current card is the same as the one presented immediately before it, or "NO" if it is not the same. Assessed at baseline and weekly for three weeks.

  Week 3

• Change from Baseline to Week 3 Working Memory Score

  In this N-back One Back test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card is the same as the previous card. The subject should press the "YES" button if the current card is the same as the one presented immediately before it, or "NO" if it is not the same. Assessed at baseline and weekly for three weeks. Change = (Week 3 Working Memory Score - Baseline Working Memory Score).

  Baseline and Week 3

• Baseline Sleep Quality Score

  The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about sleep quality while the second question about sleep quality is scaled. Possible scores range from 0 (worst sleep quality) to 10 (best sleep quality).

  Baseline

• Week 1 Sleep Quality Score

  The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about sleep quality while the second question about sleep quality is scaled. Possible scores range from 0 (worst sleep quality) to 10 (best sleep quality).

  Week 1

• Week 2 Sleep Quality Score

  The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about sleep quality while the second question about sleep quality is scaled. Possible scores range from 0 (worst sleep quality) to 10 (best sleep quality).

  Week 2

• Week 3 Sleep Quality Score

  The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about sleep quality while the second question about sleep quality is scaled. Possible scores range from 0 (worst sleep quality) to 10 (best sleep quality).

  Week 3

• Change from Baseline to Week 3 Sleep Quality Score

  The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about sleep quality while the second question about sleep quality is scaled. Possible scores range from 0 (worst sleep quality) to 10 (best sleep quality). Change = (Week 3 Sleep Quality Score - Baseline Sleep Quality Score).

  Week 3

• Baseline Pain Score

  The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about pain while the second question about pain is scaled. Possible scores range from 0 (no pain) to 10 (worst pain).

  Baseline

• Week 1 Pain Score

  The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about pain while the second question about pain is scaled. Possible scores range from 0 (no pain) to 10 (worst pain).

  Week 1

• Week 2 Pain Score

  The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about pain while the second question about pain is scaled. Possible scores range from 0 (no pain) to 10 (worst pain).

  Week 2

• Week 3 Pain Score

  The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about pain while the second question about pain is scaled. Possible scores range from 0 (no pain) to 10 (worst pain).

  Week 3

• Change from Baseline to Week 3 Pain Score

  The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about pain while the second question about pain is scaled. Possible scores range from 0 (no pain) to 10 (worst pain).

  Baseline to Week 3

• Baseline Mood Score

  The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about mood while the second question about mood is scaled. Possible scores range from 0 (worst mood) to 10 (best mood).

  Baseline

• Week 1 Mood Score

  The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about mood while the second question about mood is scaled. Possible scores range from 0 (worst mood) to 10 (best mood).

  Week 1

• Week 2 Mood Score

  The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about mood while the second question about mood is scaled. Possible scores range from 0 (worst mood) to 10 (best mood).

  Week 2

• Week 3 Mood Score

  The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about mood while the second question about mood is scaled. Possible scores range from 0 (worst mood) to 10 (best mood).

  Week 3

• Change from Baseline to Week 3 Mood Score

  The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about mood while the second question about mood is scaled. Possible scores range from 0 (worst mood) to 10 (best mood).

  Baseline to Week 3

• Baseline Overall Well-Being Score

  The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about overall well-being while the second question about overall well-being is scaled. Possible scores range from 0 (worst overall well-being) to 10 (best overall well-being).

  Baseline

• Week 1 Overall Well-Being Score

  The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about overall well-being while the second question about overall well-being is scaled. Possible scores range from 0 (worst overall well-being) to 10 (best overall well-being).

  Week 1

• Week 2 Overall Well-Being Score

  The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about overall well-being while the second question about overall well-being is scaled. Possible scores range from 0 (worst overall well-being) to 10 (best overall well-being).

  Week 2

• Week 3 Overall Well-Being Score

  The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about overall well-being while the second question about overall well-being is scaled. Possible scores range from 0 (worst overall well-being) to 10 (best overall well-being).

  Week 3

• Change from Baseline to Week 3 Overall Well-Being Score

  The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about overall well-being while the second question about overall well-being is scaled. Possible scores range from 0 (worst overall well-being) to 10 (best overall well-being).

  Baseline to Week 3

Secondary Outcomes (16)

• Correlation of Change in Psychomotor Function Score and Sleep Quality Score from Baseline to Week 3

  Baseline to Week 3

• Correlation of Change in Psychomotor Function Score and Pain Score from Baseline to Week 3

  Baseline to Week 3

• Correlation of Change in Psychomotor Function Score and Mood Score from Baseline to Week 3

  Baseline to Week 3

• Correlation of Change in Psychomotor Function Score and Overall Well-Being Score from Baseline to Week 3

  Baseline to Week 3

• Correlation of Change in Attention Score and Sleep Quality Score from Baseline to Week 3

  Baseline to Week 3

Study Arms (1)

Grounded

EXPERIMENTAL

All participants will sleep on a grounding mat for at least six hours per 24-hour period.

Device: grounding mat

Interventions

grounding mat DEVICE

Participants will sleep on an Earthing Elite sleep mat produced and sold by Earthing.com

Also known as: Earthing mat

Grounded

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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;
• Have a current diagnosis of mild cognitive impairment due to Alzheimer's disease made by a medical doctor;
• Be able to spend at least 6 hours per 24-hour period sleeping or resting on the grounded 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 and administer 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.

You may not qualify if:

• All approved participants must
• 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;
• 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 in the past year. This includes natural methods and the use of any grounding devices;
• 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;
• Not be taking or have taken in the previous 30 days any of the following medications:
• 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-convulsive medications (no matter the diagnosis); h. any type of monoclonal antibody; i. any type 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:

Sponsors & Collaborators

• California Institute of Integral Studies: lead

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• Oschman JL. Charge transfer in the living matrix. J Bodyw Mov Ther. 2009 Jul;13(3):215-28. doi: 10.1016/j.jbmt.2008.06.005. Epub 2008 Jul 30.

  PMID: 19524846 RESULT

• Oschman JL. Our place in nature: reconnecting with the Earth. J Altern Complement Med. 2010 Mar;16(3):225-6. doi: 10.1089/acm.2009.0656. No abstract available.

  PMID: 20192906 RESULT

• Oschman JL. Chronic disease: are we missing something? J Altern Complement Med. 2011 Apr;17(4):283-5. doi: 10.1089/acm.2011.0101. Epub 2011 Mar 25. No abstract available.

  PMID: 21438673 RESULT

• Passi R, Doheny KK, Gordin Y, Hinssen H, Palmer C. Electrical Grounding Improves Vagal Tone in Preterm Infants. Neonatology. 2017;112(2):187-192. doi: 10.1159/000475744. Epub 2017 Jun 10.

  PMID: 28601861 RESULT

• Pavlov VA, Tracey KJ. The vagus nerve and the inflammatory reflex--linking immunity and metabolism. Nat Rev Endocrinol. 2012 Dec;8(12):743-54. doi: 10.1038/nrendo.2012.189.

  PMID: 23169440 RESULT

• Sinatra ST, Oschman JL, Chevalier G, Sinatra D. Electric Nutrition: The Surprising Health and Healing Benefits of Biological Grounding (Earthing). Altern Ther Health Med. 2017 Sep;23(5):8-16.

  PMID: 28987038 RESULT

• Sokal K, Sokal P. Earthing the human body influences physiologic processes. J Altern Complement Med. 2011 Apr;17(4):301-8. doi: 10.1089/acm.2010.0687. Epub 2011 Apr 6.

  PMID: 21469913 RESULT

• Sokal K, Sokal P. Earthing the human organism influences bioelectrical processes. J Altern Complement Med. 2012 Mar;18(3):229-34. doi: 10.1089/acm.2010.0683.

  PMID: 22420736 RESULT

• Sokal P, Sokal K. The neuromodulative role of earthing. Med Hypotheses. 2011 Nov;77(5):824-6. doi: 10.1016/j.mehy.2011.07.046.

  PMID: 21856083 RESULT

• Thayer JF. Vagal tone and the inflammatory reflex. Cleve Clin J Med. 2009 Apr;76 Suppl 2:S23-6. doi: 10.3949/ccjm.76.s2.05.

  PMID: 19376977 RESULT

• Vinuesa A, Pomilio C, Gregosa A, Bentivegna M, Presa J, Bellotto M, Saravia F, Beauquis J. Inflammation and Insulin Resistance as Risk Factors and Potential Therapeutic Targets for Alzheimer's Disease. Front Neurosci. 2021 Apr 23;15:653651. doi: 10.3389/fnins.2021.653651. eCollection 2021.

  PMID: 33967682 RESULT

• Chevalier, G, & Sinatra, ST. Emotional Stress, Heart Rate Variability, Grounding, and Improved Autonomic Tone: Clinical Applications. Integrative Medicine. 2011; 10(3): 16-21.

  RESULT

• Chevalier, G, Melvin, G, & Barsotti, T. One-Hour Contact with the Earth's Surface (Grounding) Improves Inflammation and Blood Flow-A Randomized, Double-Blind, Pilot Study. Health. 2015; 07(08): 1022-1059.

  RESULT

• Chevalier, G. Grounding the human body improves facial blood flow regulation: Results of a randomized, placebo controlled pilot study. Journal of Cosmetics, Dermatological Sciences and Applications. 2014; 04(05): 293-308

  RESULT

Related Links

• "Beware of Misinformation" from The Earthing Institute
• "How to Measure the Effect of Earthing on Body Voltage" from The Earthing Institute
• "Grounding Pain Patches: Every Medicine Cabinet Should Have Them" from The Earthing Institute
• "Medical and Medication Considerations" from The Earthing Institute

MeSH Terms

Conditions

Cognitive Dysfunction; Sleep Initiation and Maintenance Disorders; Pain; Glucocorticoid Receptor Deficiency

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrice F Jones, CPC

  California Institute of Integral Studies

  PRINCIPAL INVESTIGATOR

• Anne Huffman, PhD

  California Institute of Integral Studies

  STUDY DIRECTOR

Central Study Contacts

Patrice F Jones, CPC

CONTACT

(512) 762-1864; pfjones@mymail.ciis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student Researcher

Model Details: An interventional, single-group method that lacks random assignment and has no control group but does provide baseline and post-intervention testing.

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 21, 2021
• Study Start: September 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share