Alzheimer Disease, Depression, Anxiety, Insomnia
Conditions
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.
Interventions
DEVICEGrounding
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.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The investigators use a grounding wire and a sham grounding wire to create grounding and sham-grounding groups. The patients are blinded to the grounding because they do not know which one has a grounding effect according to the exterior of the mat. The investigators who do the evaluation of questionnaire and electrochemical analyzer and the outcomes assessor who interpret the data do not know which wire has grounding effect, too.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Taiwan
Outcome results
None listed