NCT06966921

The Effect of Cranial Electrotherapy Stimulation on the Cognition, Anxiety, Depression and Sleep Quality of Chronic Psychiatric Patients

Recruiting now NA Last updated 13 May 2025

What this trial tests

NA trial testing CES in Sleep in 92 participants. Currently enrolling.

Timeline

20 April 2025

Primary endpoint
30 September 2025

31 December 2025

Quick facts

Lead sponsor	Liu Hsing Yu
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	92
Start date	20 April 2025
Primary completion	30 September 2025
Estimated completion	31 December 2025
Sites	1 location across Taiwan

Drugs / interventions tested

• CES

Conditions studied

• Sleep — all drugs for Sleep →
• Depression Disorders — all drugs for Depression Disorders →

Sponsor

Liu Hsing Yu

Who can join

Adults 20 to 75, any sex, with Sleep or Depression Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.