SleepNCT06966921
Cranial Electrotherapy Stimulation in Chronic Psychiatric Patients
A study testing CES in people with Sleep and Depression Disorders, run by Liu Hsing Yu at 1 site in Taiwan.
Trial summary
This randomized, gender-stratified study evaluated cranial electrotherapy stimulation (CES) in residents with chronic psychiatric disorders living in a psychiatric nursing home. Seventy participants were randomly assigned to early CES or delayed CES (35 per group). Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Sleep, Depression Disorders
- What is being tested?
- CES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Apr 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1. Those with obvious risk of violence or suicide 2. People with cognitive impairment who have been diagnosed with mental retardation or autism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cranial Electrotherapy Stimulation on the Cognition, Anxiety, Depression and Sleep Quality of Chronic Psychiatric Patients
This randomized, gender-stratified study evaluated cranial electrotherapy stimulation (CES) in residents with chronic psychiatric disorders living in a psychiatric nursing home. Seventy participants were randomly assigned to early CES or delayed CES (35 per group). The early-CES group received 40-minute sessions five days a week for 12 weeks (60 sessions). Participants were assessed at baseline, at 12 weeks, and 3 and 6 months after the 12-week period. The delayed-CES group began CES after the week-12 assessment. The study examined changes over time under these two treatment schedules.
Read the detailed description
This study evaluated cranial electrotherapy stimulation (CES) using an Alpha-Stim® device in residents with chronic psychiatric disorders. Participants were assigned by gender-stratified randomization to early CES or delayed CES, with 35 participants in each group. The early-CES group received 40-minute sessions five days per week for 12 weeks. The delayed-CES group began CES after the week-12 assessment. Assessments were conducted at baseline, at 12 weeks, and 3 and 6 months after week 12. Participants were monitored for discomfort during CES. If dizziness, skin irritation, ear discomfort, or other discomfort occurred, stimulation was stopped and the participant was evaluated by the clinical team.
- Conditions
- Sleep, Depression Disorders
- Being tested
- CES
- Keywords
- Cranial Electrotherapy Stimulation, Chronic Psychiatric Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CESDevice
Currently, most CES intervention studies are applied to the general public, and a few studies focus on athletic performance. There are no related studies on residents of psychiatric nursing homes, nor are there any research designs for improving cognitive impairment. Therefore, this study explores the use of CES programs to improve the cognition, anxiety, depression, and other conditions of residents of psychiatric care homes, with the goal of improving their quality of life.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Participants in the experimental group received cranial electrotherapy stimulation (CES) for 40 minutes per session, five sessions per week for 12 weeks (60 sessions). Receives: Device: CES |
| control group | No intervention | Participants in the control group received routine care without CES until the week-12 assessment. After the assessment, they received CES for 40 minutes per session, five days per week for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep
The Pittsburgh Sleep Quality Inventory (PSQI) is a self-administered questionnaire developed by Buysse et al. (1989). They felt that sleep quality has become an important issue in clinical practice, so they referred to the existing sleep quality scale and developed it into a self-administered questionnaire that can explore sleep conditions in the past month. This scale can be used as a self-assessment tool to measure sleep quality. Its content covers seven sub-concepts, including self-assessed sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of sleeping pills, and daytime function.
Measured: "From enrollment to the end of treatment at 12 weeks"
Depression
This study used the Taiwanese Depression Scale (TDS) revised by scholar Yu (2011). The purpose of this scale is to screen cases with depressive symptoms. It has a total of 18 questions, and each question is divided into 0 points (no or very few symptoms), 1 point (sometimes there are symptoms), 2 points (often there are symptoms), and 3 points (often or always there are symptoms) according to the severity. The total score ranges from 0 to 54 points. The higher the score, the more severe the depressive symptoms (Yu, Huang, and Liu, 2011).
Lee et al. conducted a reliability and validity analysis on 107 community residents using this scale and found that the internal consistency Cronbach's alpha coefficient was 0.90.
The DSM III-R (Edition, Revised) was used as the diagnostic standard. After the receiver operating characteristic curve (ROC) analysis, it was found that the total score of 19 points was the best cut-off point for diagnosing depression, with a sensitivity of 0.89 and a speci
Measured: "From enrollment to the end of treatment at 12weeks"
Secondary outcomes (2)
cognition
In this study, the Chinese version of the Montreal Cognitive Assessment (MoCA) was used to assess the cognitive status of the cases. The test was administered once before and after the intervention to evaluate whether the intervention measures had an effect on improving the cognitive function of the cases.
Measured: "From enrollment to the end of treatment at 12 weeks"
anxiety
This study used the State-Trait Anxiety Inventory to assess the anxiety status of the patients. The test was administered once before and after the intervention to assess whether the intervention measures had an effect on improving the anxiety of the patients.
Measured: "From enrollment to the end of treatment at 12 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start20 Apr 2025
- Primary completion30 Sep 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liu Hsing Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu Hsing Yu, TsaoTun Psychiatric Center, Department of Health, Taiwan
- Investigators
- Hsing yu Liu, Principal investigator, Tsaotun Psychiatric Center, MOHW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966921
- Sponsor's protocol ID
- 113019
- Status last verified
- Sep 2026
- First submitted
- 17 Apr 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cranial Electrotherapy Stimulation on the Cognition, Anxiety, Depression and Sleep Quality of Chronic Psychiatric Patients
- ClinicalTrials.gov ID
- NCT06966921
- Acronym / sponsor ID
- 113019
- Conditions
- Sleep, Depression Disorders
- Keywords
- Cranial Electrotherapy Stimulation, Chronic Psychiatric Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Liu Hsing YuUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, gender-stratified study evaluated cranial electrotherapy stimulation (CES) in residents with chronic psychiatric disorders living in a psychiatric nursing home. Seventy participants were randomly assigned to early CES or delayed CES (35 per group). The early-CES group received 40-minute sessions five days a week for 12 weeks (60 sessions). Participants were assessed at baseline, at 12 weeks, and 3 and 6 months after the 12-week period. The delayed-CES group began CES after the week-12 assessment. The study examined changes over time under these two treatment schedules.
Detailed description
This study evaluated cranial electrotherapy stimulation (CES) using an Alpha-Stim® device in residents with chronic psychiatric disorders. Participants were assigned by gender-stratified randomization to early CES or delayed CES, with 35 participants in each group. The early-CES group received 40-minute sessions five days per week for 12 weeks. The delayed-CES group began CES after the week-12 assessment. Assessments were conducted at baseline, at 12 weeks, and 3 and 6 months after week 12. Participants were monitored for discomfort during CES. If dizziness, skin irritation, ear discomfort, or other discomfort occurred, stimulation was stopped and the participant was evaluated by the clinical team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: CESParticipants in the experimental group received cranial electrotherapy stimulation (CES) for 40 minutes per session, five sessions per week for 12 weeks (60 sessions). |
| control group | No intervention | –Participants in the control group received routine care without CES until the week-12 assessment. After the assessment, they received CES for 40 minutes per session, five days per week for 12 weeks. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Those with obvious risk of violence or suicide 2. People with cognitive impairment who have been diagnosed with mental retardation or autism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CESCurrently, most CES intervention studies are applied to the general public, and a few studies focus on athletic performance. There are no related studies on residents of psychiatric nursing homes, nor are there any research designs for improving cognitive impairment. Therefore, this study explores the use of CES programs to improve the cognition, anxiety, depression, and other conditions of residents of psychiatric care homes, with the goal of improving their quality of life. | Device | experimental group |
Primary outcome
sleep
Time frame: "From enrollment to the end of treatment at 12 weeks"
The Pittsburgh Sleep Quality Inventory (PSQI) is a self-administered questionnaire developed by Buysse et al. (1989). They felt that sleep quality has become an important issue in clinical practice, so they referred to the existing sleep quality scale and developed it into a self-administered questionnaire that can explore sleep conditions in the past month. This scale can be used as a self-assessment tool to measure sleep quality. Its content covers seven sub-concepts, including self-assessed sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of sleeping pills, and daytime function.
Depression
Time frame: "From enrollment to the end of treatment at 12weeks"
This study used the Taiwanese Depression Scale (TDS) revised by scholar Yu (2011). The purpose of this scale is to screen cases with depressive symptoms. It has a total of 18 questions, and each question is divided into 0 points (no or very few symptoms), 1 point (sometimes there are symptoms), 2 points (often there are symptoms), and 3 points (often or always there are symptoms) according to the severity. The total score ranges from 0 to 54 points. The higher the score, the more severe the depressive symptoms (Yu, Huang, and Liu, 2011). Lee et al. conducted a reliability and validity analysis on 107 community residents using this scale and found that the internal consistency Cronbach's alpha coefficient was 0.90. The DSM III-R (Edition, Revised) was used as the diagnostic standard. After the receiver operating characteristic curve (ROC) analysis, it was found that the total score of 19 points was the best cut-off point for diagnosing depression, with a sensitivity of 0.89 and a speci
2 secondary outcomes
cognition
Time frame: "From enrollment to the end of treatment at 12 weeks"
anxiety
Time frame: "From enrollment to the end of treatment at 12 weeks"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsing yu Liu principal investigator
Tsaotun Psychiatric Center, MOHW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CES in people with Sleep and Depression Disorders, run by Liu Hsing Yu at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep (time frame: "From enrollment to the end of treatment at 12 weeks"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.