Alzheimer DiseaseNCT05246332
Grounding Effect on Alzheimer's Disease
A study testing Grounding in people with Alzheimer Disease and Insomnia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The investigators explore the effectiveness of grounding as a non-pharmacological therapy for treating sleep disturbances, anxiety, and depression in patients with mild AD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease, Insomnia, Depression, Anxiety
- What is being tested?
- Grounding
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2019to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with dementia, and CDR ≥ 0.5
- aged > 50 years,
- sit with bilateral bare feet on the grounding mat
- able to answer the questionnaire
- able to sign the informed consent adequately.
Who cannot join
- aged less than 50 years
- inability to sit with bilateral bare feet on the grounding mat
- currently taking anti-oxidative health supplements or anti-inflammatory medicine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Grounding the Body Improves Sleep Quality in Patients With Mild Alzheimer's Disease
The investigators explore the effectiveness of grounding as a non-pharmacological therapy for treating sleep disturbances, anxiety, and depression in patients with mild AD.
Read the detailed description
Grounding refers to having direct contact with the Earth, such as walking barefoot or lying on the ground. Research has found that grounding can improve inflammation, free radical damage, blood pressure, sleep quality, pain, stress, mood, and wound healing. However, there has been no re-search on the effect of utilizing grounding for patients with Alzheimer's disease (AD). Thus, in this study, the investigators explore the effectiveness of grounding as a non-pharmacological therapy for treating sleep disturbances, anxiety, and depression in patients with mild AD.
Patients with mild AD were enrolled in the study. The electrochemical analyzer CHI 1205b was employed to check the electrochemical signals at acupoints KI1 and GV16. The investigators used the Pittsburgh Sleep Quality Index (PSQI), Beck Anxiety Inventory (BAI), and Beck Depression Inventory-II (BDI-II) to evaluate sleep quality, anxiety, and depression, respectively, at weeks 0 and 12.
- Conditions
- Alzheimer Disease, Insomnia, Depression, Anxiety
- Being tested
- Grounding
- Medical subject headings
- Alzheimer Disease, Sleep Initiation and Maintenance Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GroundingDevice
The investigators used a grounding wire and a sham grounding wire to create grounding and sham-grounding groups. Participants sat on a chair barefoot in contact with the grounding mat for 30 minutes. The participants were blinded to the grounding because they did not know which one had a grounding effect according to the exterior of the mat.
| Study group | Role | What they receive |
|---|---|---|
| Patient receive grounding | Experimental | The investigators use the grounding mat (EARTHING Conductive Earthing Uni-versal Mat with Earthing Cord) as the grounding method. The grounding group use a grounding wire to sit on a chair barefoot in contact with the grounding mat for 30 minutes. Receives: Device: Grounding |
| Patient receive sham-grounding | Sham comparator | The investigators use the grounding mat (EARTHING Conductive Earthing Uni-versal Mat with Earthing Cord) as the grounding method. The sham-grounding group use a sham grounding wire to sit on a chair barefoot in contact with the grounding mat for 30 minutes. Receives: Device: Grounding |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pittsburgh Sleep Quality Index (PSQI) questionnaire for insomnia, score range from 0 to 21, the higher score means worse sleep quality
The investigators measure Pittsburgh Sleep Quality Index (PSQI) score before the patients participate the study (week 0, baseline data). After receiving 12 weeks grounding, the investigators measure PSQI again (week 12, post grounding data).
Measured: through study completion, an average of 12 weeks.
The Beck Anxiety Inventory (BAI) questionnaire for anxiety, score range from 0 to 63, the higher score means more anxiety the patient is.
The investigators measure Beck Anxiety Inventory (BAI) score before the patients participate the study (week 0, baseline data). After receiving 12 weeks grounding, the investigators measure BAI again (week 12, post grounding data).
Measured: through study completion, an average of 12 weeks.
The Beck Depression Inventory-II (BDI-II) questionnaire for depression, score range from 0 to 63, the higher score means more depression the patient is.
The investigators measure Beck Depression Inventory-II (BDI-II) score before the patients participate the study (week 0, baseline data). After receiving 12 weeks grounding, the investigators measure BDI-II again (week 12, post grounding data).
Measured: through study completion, an average of 12 weeks.
The electric current
The electrochemical analyzer CHI 1205b is a device that can measure the electric current via reduction-oxidation reaction.
The investigators measure the electric current before the patients participate the study (week 0, baseline data). After receiving 12 weeks grounding, the investigators measure the electric current again (week 12, post grounding data).
Measured: through study completion, an average of 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Aug 2019
- Primary completion12 Aug 2019
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nai-Ching Chen, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246332
- Sponsor's protocol ID
- 201901136B0
- Status last verified
- Aug 2019
- First submitted
- 9 Feb 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Menigoz W, Latz TT, Ely RA, Kamei C, Melvin G, Sinatra D. Integrative and lifestyle medicine strategies should include Earthing (grounding): Review of research evidence and clinical observations. Explore (NY). 2020 May-Jun;16(3):152-160. doi: 10.1016/j.explore.2019.10.005. Epub 2019 Nov 14.
PubMed 31831261Figueiro MG, Plitnick B, Roohan C, Sahin L, Kalsher M, Rea MS. Effects of a Tailored Lighting Intervention on Sleep Quality, Rest-Activity, Mood, and Behavior in Older Adults With Alzheimer Disease and Related Dementias: A Randomized Clinical Trial. J Clin Sleep Med. 2019 Dec 15;15(12):1757-1767. doi: 10.5664/jcsm.8078. Epub 2019 Nov 8.
PubMed 31855161Whitney MS, Shemery AM, Yaw AM, Donovan LJ, Glass JD, Deneris ES. Adult Brain Serotonin Deficiency Causes Hyperactivity, Circadian Disruption, and Elimination of Siestas. J Neurosci. 2016 Sep 21;36(38):9828-42. doi: 10.1523/JNEUROSCI.1469-16.2016.
PubMed 27656022
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grounding the Body Improves Sleep Quality in Patients With Mild Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05246332
- Acronym / sponsor ID
- 201901136B0
- Conditions
- Alzheimer Disease, Insomnia, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators explore the effectiveness of grounding as a non-pharmacological therapy for treating sleep disturbances, anxiety, and depression in patients with mild AD.
Detailed description
Grounding refers to having direct contact with the Earth, such as walking barefoot or lying on the ground. Research has found that grounding can improve inflammation, free radical damage, blood pressure, sleep quality, pain, stress, mood, and wound healing. However, there has been no re-search on the effect of utilizing grounding for patients with Alzheimer's disease (AD). Thus, in this study, the investigators explore the effectiveness of grounding as a non-pharmacological therapy for treating sleep disturbances, anxiety, and depression in patients with mild AD.
Patients with mild AD were enrolled in the study. The electrochemical analyzer CHI 1205b was employed to check the electrochemical signals at acupoints KI1 and GV16. The investigators used the Pittsburgh Sleep Quality Index (PSQI), Beck Anxiety Inventory (BAI), and Beck Depression Inventory-II (BDI-II) to evaluate sleep quality, anxiety, and depression, respectively, at weeks 0 and 12.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient receive grounding | Experimental | Device: GroundingThe investigators use the grounding mat (EARTHING Conductive Earthing Uni-versal Mat with Earthing Cord) as the grounding method. The grounding group use a grounding wire to sit on a chair barefoot in contact with the grounding mat for 30 minutes. |
| Patient receive sham-grounding | Sham comparator | Device: GroundingThe investigators use the grounding mat (EARTHING Conductive Earthing Uni-versal Mat with Earthing Cord) as the grounding method. The sham-grounding group use a sham grounding wire to sit on a chair barefoot in contact with the grounding mat for 30 minutes. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosed with dementia, and CDR ≥ 0.5
- aged > 50 years,
- sit with bilateral bare feet on the grounding mat
- able to answer the questionnaire
- able to sign the informed consent adequately.
Key exclusion criteria (3 listed)
- aged less than 50 years
- inability to sit with bilateral bare feet on the grounding mat
- currently taking anti-oxidative health supplements or anti-inflammatory medicine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GroundingThe investigators used a grounding wire and a sham grounding wire to create grounding and sham-grounding groups. Participants sat on a chair barefoot in contact with the grounding mat for 30 minutes. The participants were blinded to the grounding because they did not know which one had a grounding effect according to the exterior of the mat. | Device | Patient receive grounding, Patient receive sham-grounding |
Primary outcome
The Pittsburgh Sleep Quality Index (PSQI) questionnaire for insomnia, score range from 0 to 21, the higher score means worse sleep quality
Time frame: through study completion, an average of 12 weeks.
The investigators measure Pittsburgh Sleep Quality Index (PSQI) score before the patients participate the study (week 0, baseline data). After receiving 12 weeks grounding, the investigators measure PSQI again (week 12, post grounding data).
The Beck Anxiety Inventory (BAI) questionnaire for anxiety, score range from 0 to 63, the higher score means more anxiety the patient is.
Time frame: through study completion, an average of 12 weeks.
The investigators measure Beck Anxiety Inventory (BAI) score before the patients participate the study (week 0, baseline data). After receiving 12 weeks grounding, the investigators measure BAI again (week 12, post grounding data).
The Beck Depression Inventory-II (BDI-II) questionnaire for depression, score range from 0 to 63, the higher score means more depression the patient is.
Time frame: through study completion, an average of 12 weeks.
The investigators measure Beck Depression Inventory-II (BDI-II) score before the patients participate the study (week 0, baseline data). After receiving 12 weeks grounding, the investigators measure BDI-II again (week 12, post grounding data).
The electric current
Time frame: through study completion, an average of 12 weeks.
The electrochemical analyzer CHI 1205b is a device that can measure the electric current via reduction-oxidation reaction. The investigators measure the electric current before the patients participate the study (week 0, baseline data). After receiving 12 weeks grounding, the investigators measure the electric current again (week 12, post grounding data).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Background: PubMed 31831261Menigoz W, Latz TT, Ely RA, Kamei C, Melvin G, Sinatra D. Integrative and lifestyle medicine strategies should include Earthing (grounding): Review of research evidence and clinical observations. Explore (NY). 2020 May-Jun;16(3):152-160. doi: 10.1016/j.explore.2019.10.005. Epub 2019 Nov 14.
- Background: PubMed 31855161Figueiro MG, Plitnick B, Roohan C, Sahin L, Kalsher M, Rea MS. Effects of a Tailored Lighting Intervention on Sleep Quality, Rest-Activity, Mood, and Behavior in Older Adults With Alzheimer Disease and Related Dementias: A Randomized Clinical Trial. J Clin Sleep Med. 2019 Dec 15;15(12):1757-1767. doi: 10.5664/jcsm.8078. Epub 2019 Nov 8.
- Background: PubMed 27656022Whitney MS, Shemery AM, Yaw AM, Donovan LJ, Glass JD, Deneris ES. Adult Brain Serotonin Deficiency Causes Hyperactivity, Circadian Disruption, and Elimination of Siestas. J Neurosci. 2016 Sep 21;36(38):9828-42. doi: 10.1523/JNEUROSCI.1469-16.2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nai-Ching Chen, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grounding in people with Alzheimer Disease and Insomnia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pittsburgh Sleep Quality Index (PSQI) questionnaire for insomnia, score range from 0 to 21, the higher score means worse sleep quality (time frame: through study completion, an average of 12 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05246332, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.