InsomniaNCT05445999
A Preliminary Study of Model-driven Individualized Transcranial Electrical Stimulation for Insomnia
A study testing High-Definition transcranial electrical stimulation in people with Insomnia, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
This study is designed to evaluate the efficacy and to explore the best individualized stimulus paradigm of transcranial Electrical Stimulation for insomnia patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Insomnia
- What is being tested?
- High-Definition transcranial electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Sep 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Participants will be recruited from the Shanghai Mental Health Center (SMHC) in Shanghai. Eligible insomnia participants were adults (18-50 years at SMHC) and diagnosed with insomnia disorder according to DSM-5 criteria by neurologists or psychiatrists using the procedure of Mini-International Neuropsychiatric Interview. Inclusion criteria were: (1) ≥ 9 years of education, (2) medication-free or had received stable medication for at least 2 months before entering the study and continued the same medication throughout the study. Exclusion criteria included: (1) serious medical, neurological, or psychiatric disorders other than anxiety or mild-to-moderate depression secondary to insomnia, (2) obstructive sleep apnea syndrome, (3) pregnancy or recent preparation for pregnancy, (4) previous treatments with ECT, rTMS, tES, and CBT-I.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200234
About this study
This study is designed to evaluate the efficacy and to explore the best individualized stimulus paradigm of transcranial Electrical Stimulation for insomnia patients.
Read the detailed description
This study is an open-label clinical trial. A total of 40 patients with insomnia who meet the inclusion and exclusion of criteria will be recruited from the SMHC (20) and be assigned to receive individualized tDCS treatment. Patients will undergo ten days of daily individualized tDCS treatment for 20 min (sessions 2-11, SMHC) over a two-week period, which session 7 of patients for re-screening of tDCS target. In addition, normal control subjects and insomnia patients meeting eligibility criteria will be recruited from SMHC to identify biomarkers of wakefulness and sleep through simultaneous fMRI-EEG and high-density EEG recordings. These participants will not receive tDCS and will serve as controls for comparison with the treatment group.
- Conditions
- Insomnia
- Being tested
- High-Definition transcranial electrical stimulation
- Keywords
- Transcranial electrical stimulation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Definition transcranial electrical stimulationDevice
The first and final sessions will include clinical assessments and acquisition of MRI and EEG data. To minimize variability, each patient will undergo tDCS at a consistent time in the afternoon or evening and will remain lying in bed with eyes closed throughout stimulation. Stimulation will be delivered using the GTEN 200 system (Magstim EGI, Oregon, USA), which also enables simultaneous EEG recording. The stimulation current will be limited to 1.5 mA, with a maximum of 0.15 mA per electrode (up to 20 electrodes). Electrode placement and current intensity will be individualized to achieve the targeted electric field strength (0.1 or 0.2 V/m at SMHC;). Each session will include 5 min of resting-state EEG immediately before and after stimulation to assess tDCS-induced changes in brain dynamics. Current onset and offset will be gradual, with 2-s ramp-up and ramp-down periods.
| Study group | Role | What they receive |
|---|---|---|
| tES treatment | Experimental | Patients will receive ten sessions of daily individualized tDCS over a two-week period, delivered for 20 min at SMHC (sessions 2-11). Receives: Device: High-Definition transcranial electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
The primary outcome is measured as the Insomnia Severity Index (ISI) at baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6, SMHC).
Measured: At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6, SMHC)
Secondary outcomes (6)
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI)
Measured: At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6)
Change in Beck Depression Inventory, BDI
It consists of 21 items and uses a 0 to 3 severity scale. Total scores range from 0 to 63, with higher scores indicating more severe depression symptoms.
Measured: At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6)
Change in Beck Anxiety Inventory, BAI
It is an inventory of anxiety symptoms with 18 items that are rated on a 5-point Likert scale(0 to 4). Total scores range from 0 to 72, with higher scores indicating more severe anxiety symptoms.
Measured: At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6)
Change in Side-effect questionnaire
It consists of 10-item and uses 0 to 3 severity scale to rate the intensity of side effects. Total scores range from 0 to 30, with higher scores indicating more severe side-effect. It also assesses the relation between side-effect and the effects of tDCS using 0 to 4 scale. Total scores range from 0 to 40, with higher score indicating the greater relation.
Measured: At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6).
sleep Diary
A daily record of sleep-wake times and related lifestyle factors, such as caffeine intake, naps, and exercise, used to identify patterns and improve sleep
Measured: At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3)
Remission Rate
Defined as ISI<8 based on the previous study
Measured: week 2, weeks 3 and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start1 Jan 2023
- Primary completion30 Dec 2024
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Wang, Shanghai Mental Health Center
- Investigators
- Zhen Wang, PhD,MD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445999
- Sponsor's protocol ID
- SMHC-ISM-001
- Status last verified
- Sep 2025
- First submitted
- 28 Jun 2022
- Last updated
- 25 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study of Model-driven Individualized Transcranial Electrical Stimulation for Insomnia
- ClinicalTrials.gov ID
- NCT05445999
- Acronym / sponsor ID
- SMHC-ISM-001
- Conditions
- Insomnia
- Keywords
- Transcranial electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 6 Jul 2022 (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 study is designed to evaluate the efficacy and to explore the best individualized stimulus paradigm of transcranial Electrical Stimulation for insomnia patients.
Detailed description
This study is an open-label clinical trial. A total of 40 patients with insomnia who meet the inclusion and exclusion of criteria will be recruited from the SMHC (20) and be assigned to receive individualized tDCS treatment. Patients will undergo ten days of daily individualized tDCS treatment for 20 min (sessions 2-11, SMHC) over a two-week period, which session 7 of patients for re-screening of tDCS target. In addition, normal control subjects and insomnia patients meeting eligibility criteria will be recruited from SMHC to identify biomarkers of wakefulness and sleep through simultaneous fMRI-EEG and high-density EEG recordings. These participants will not receive tDCS and will serve as controls for comparison with the treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tES treatment | Experimental | Device: High-Definition transcranial electrical stimulationPatients will receive ten sessions of daily individualized tDCS over a two-week period, delivered for 20 min at SMHC (sessions 2-11). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| High-Definition transcranial electrical stimulationThe first and final sessions will include clinical assessments and acquisition of MRI and EEG data. To minimize variability, each patient will undergo tDCS at a consistent time in the afternoon or evening and will remain lying in bed with eyes closed throughout stimulation. Stimulation will be delivered using the GTEN 200 system (Magstim EGI, Oregon, USA), which also enables simultaneous EEG recording. The stimulation current will be limited to 1.5 mA, with a maximum of 0.15 mA per electrode (up to 20 electrodes). Electrode placement and current intensity will be individualized to achieve the targeted electric field strength (0.1 or 0.2 V/m at SMHC;). Each session will include 5 min of resting-state EEG immediately before and after stimulation to assess tDCS-induced changes in brain dynamics. Current onset and offset will be gradual, with 2-s ramp-up and ramp-down periods. | Device | tES treatment |
Primary outcome
Insomnia Severity Index
Time frame: At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6, SMHC)
The primary outcome is measured as the Insomnia Severity Index (ISI) at baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6, SMHC).
6 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6)
Change in Beck Depression Inventory, BDI
Time frame: At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6)
Change in Beck Anxiety Inventory, BAI
Time frame: At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6)
Change in Side-effect questionnaire
Time frame: At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6).
sleep Diary
Time frame: At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3)
Remission Rate
Time frame: week 2, weeks 3 and week 6
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 25 Sep 2025.
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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.
Zhen Wang, PhD,MD principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Definition transcranial electrical stimulation in people with Insomnia, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 25 Sep 2025. 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 China. 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?
Insomnia Severity Index (time frame: At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6, SMHC)). 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 25 Sep 2025.