NCT06966921 The Effect of Cranial Electrotherapy Stimulation on the Cognition, Anxiety, Depression and Sleep Quality of Chronic Psychiatric Patients
| NCT ID | NCT06966921 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Liu Hsing Yu |
| Condition | Sleep |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2025-04-20 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 92 participants in total. It began in 2025-04-20 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
1. Research background Residents of nursing homes are chronically ill patients who are placed in long-term homes. Studies have shown that most residents live alone and are prone to loneliness, loss, depression, and anxiety (Lapane et al., 2022). Cranial electrostimulation (CES) can improve anxiety, depression, and sleep, but there are few studies on the cognitive status of patients with chronic mental illness. 2. Research purpose This study uses cranial microcurrent stimulation (CES) to improve cognition, anxiety, depression, sleep and other conditions in patients with chronic mental illness, with the aim of improving their quality of life. 3. Screening criteria for respondents 3.1 Inclusion criteria (Those who meet the following criteria are suitable to participate in this study) 1\. Chronic mental illness patients, 2. Mini-Mental State Examination (MMSE) ≥ 16 points, 3. Education level is junior high school graduates or above, 4. Appropriate oral expression ability, 5. Those who can complete the research consent form, 6. Those who are willing to participate in this study Exclusion conditions (If you have the following conditions, you cannot participate in this study) 1\. Those with obvious risk of violence or suicide; 2. Those with cognitive impairment diagnosed with intellectual disability or autism 4. Research Methods 1. The study was conducted at the Psychiatric Center 2. A total of 92 people were admitted, and they were randomly grouped. 3. This study is a interventional study. Before the intervention, a questionnaire must be filled out, which takes about 30 minutes. Then CES is performed 5 times a week, each time for 40 minutes. After completion, the questionnaire must be filled out again. After 3 months of follow-up, another questionnaire test will be conducted. 4. Possible discomfort and treatment methods During the CES intervention, if you feel dizzy, skin allergies, ear discomfort, or any discomfort, the intervention will be stopped immediately and the medical team will evaluate and treat you. 5. Expected benefits of the study This study uses cranial electrostimulation (CES) to improve cognition, anxiety, depression, sleep and other conditions in patients with chronic mental illness, with the aim of improving their quality of life. 6 Matters that respondents should cooperate with during the research Express your true inner thoughts on the questionnaire content. 7 Confidentiality This study collects data through questionnaires. All identifiable data will be coded to ensure personal data security and case privacy. 8\. Subsidies and Damages Respondents who complete the research data collection will receive a gift voucher worth approximately NT$300
Eligibility Criteria
Inclusion Criteria: * 1\. Chronic mental illness patients, 2. Mini-Mental State Examination (MMSE) ≥ 16 points, 3. Education level is junior high school graduates or above, 4. Appropriate oral expression ability, 5. Those who can complete the research consent form, 6. Those who are willing to participate in this study Exclusion Criteria: * 1\. Those with obvious risk of violence or suicide 2. People with cognitive impairment who have been diagnosed with mental retardation or autism
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06966921 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 75 Years, studying Sleep. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06966921 currently recruiting?
Yes, NCT06966921 is actively recruiting participants. Contact the research team at hsingyuliu76@gmail.com for enrollment information.
Where is the NCT06966921 trial being conducted?
This trial is being conducted at Nantou City, Taiwan.
Who is sponsoring the NCT06966921 clinical trial?
NCT06966921 is sponsored by Liu Hsing Yu. The trial plans to enroll 92 participants.