Model-Driven Individualized Transcranial Direct Current Stimulation for the Treatment of Insomnia Disorders
Recruiting
N/AInterventional Study
Insomnia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Zhen Wang · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 65 who have insomnia. Participants will receive a type of brain stimulation to help improve their sleep.
Are You a Good Fit for This Trial?
Must not be takingBenzodiazepines
Rules you outSevere negative thoughtsPregnancy or planning to conceive soon
You may be able to join if
I am between 18 and 65 years old
I have been diagnosed with insomnia disorder
I have not taken psychiatric medications in the past 8 weeks or have been stable on them for that time (not including benzodiazepines)
I have an insomnia severity score over 10
I have completed at least junior high school
You may not be able to join if
I have been diagnosed with any disorder other than insomnia, anxiety, or depression
I am currently using benzodiazepines as sleep aids
I have moderate to severe anxiety or depression
I have obstructive sleep apnea syndrome
I have had previous treatment for insomnia disorder with ECT, rTMS, tES, or cognitive behavioral therapy
I have severe physical illnesses or conditions that might cause seizures
I have a history of neurological disorders or brain injuries
I have an implantable medical device
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This study is designed to evaluate the efficacy and to explore the best individualized stimulus paradigm of transcranial Electrical Stimulation for insomnia patients.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age between 18 and 65 years;
2. Meets the diagnostic criteria for insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
3. Has not taken psychiatric medications in the 8 weeks prior to enrollment or has been on stable …
Inclusion Criteria:
1. Age between 18 and 65 years;
2. Meets the diagnostic criteria for insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
3. Has not taken psychiatric medications in the 8 weeks prior to enrollment or has been on stable psychiatric medication for 8 weeks (excluding benzodiazepines);
4. Insomnia severity as indicated by an ISI score \> 10;
5. Minimum education level of junior high school or above.
Exclusion Criteria:
1. Past or current diagnosis of disorders other than insomnia disorder, anxiety disorder, or depressive disorder according to DSM-5;
2. Currently using benzodiazepines as sleep aids;
3. Moderate to severe anxiety or depression (HAMD-17 score \> 16 or HAMA score \> 24);
4. Patients with obstructive sleep apnea syndrome;
5. Previous treatment with ECT, rTMS, tES, or cognitive behavioral therapy for insomnia disorder;
6. Severe physical illnesses or any condition that may induce seizures or intracranial hypertension, including cardiovascular or respiratory diseases;
7. History of neurological disorders (e.g., epilepsy, cerebrovascular accidents) or history of brain injury or brain surgery;
8. Presence of implantable medical devices such as intracranial stents, cardiac pacemakers, coronary stents, or cochlear implants;
9. Severe negative thoughts or high suicide risk;
10. Pregnant or planning to conceive in the near future.
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