Grounding Effect on Alzheimer's Disease

Not Applicable

Completed

• Conditions: Depression, Anxiety; Alzheimer Disease; Insomnia

• Registration Number: NCT05246332
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Status Verified: 2019-08
• Study Start: 2019-08-01
• Primary Completion: 2019-08-12
• Study Completion: 2020-07-31
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-09
• Last Update Submitted: 2022-02-09
• Study First Posted: 2022-02-18
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Pittsburgh Sleep Quality Index (PSQI) questionnaire for insomnia, score range from 0 to 21, the higher score means worse sleep quality	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.	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.	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	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).

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan