Clinical trial NCT05246332: Grounding Effect on Alzheimer's Disease
Official title: Grounding the Body Improves Sleep Quality in Patients With Mild Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Insomnia
Depression, Anxiety
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The Pittsburgh Sleep Quality Index (PSQI) questionnaire for insomnia, score range from 0 to 21, the higher score means worse sleep quality
timeFrame: through study completion, an average of 12 weeks.
measure: The Beck Anxiety Inventory (BAI) questionnaire for anxiety, score range from 0 to 63, the higher score means more anxiety the patient is.
timeFrame: through study completion, an average of 12 weeks.
measure: 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.
timeFrame: through study completion, an average of 12 weeks.
measure: The electric current
timeFrame: through study completion, an average of 12 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Nai-Ching Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Figueiro 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.
citation: Whitney 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.