Sleep disorders
Conditions
Interventions
Experimental group:Transcranial time-interference stimulation
Sponsors
Suzhou Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients who meet the stroke diagnostic criteria established at the 4th National Cerebrovascular Disease Conference, and whose condition has been confirmed as either a first-onset or recurrent acute ischemic or hemorrhagic stroke through cranial CT or MRI examinations. 2. Age 18–80 years old, with a stroke occurring within 3 months to 2 years prior to enrollment. 3. Meet the diagnostic criteria for post-stroke sleep disorders (PSSDs) or sleep disorders associated with stroke as outlined in the "2023 Chinese Expert Consensus on the Assessment and Management of Stroke-Related Sleep Disorders". Special attention should be paid to insomnia, excessive daytime sleepiness (EDS), and circadian-rhythm-related sleep-wake disorders. 4. The patient is conscious, able to understand and cooperate with all assessments and procedures. The Mini-Mental State Examination (MMSE) score is >=18 points (or the threshold adjusted according to the patient’s level of education). 5. Basic vital signs such as blood pressure, heart rate, and respiration are relatively stable, with no severe cardiopulmonary dysfunction. 6. After fully understanding the purpose, methods, potential risks, and benefits of the study, the patient or their legal representative voluntarily signs the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Other primary severe sleep disorders, such as untreated moderate to severe obstructive sleep apnea (OSA, with an Apnea-Hypopnea Index AHI of >15 episodes per hour, accompanied by significant daytime sleepiness or cardiovascular complications), narcolepsy, periodic limb movement disorder (PLMD), etc. Patients with mild OSA (AHI 5–15 episodes per hour) without significant daytime symptoms, or those with OSA who have received effective CPAP treatment and have stable conditions, may be included in the study at the discretion of the researchers, depending on the specific circumstances. 2. Severe mental illnesses, such as schizophrenia, acute episodes of bipolar disorder, severe depression with suicidal tendencies or psychotic symptoms, and severe anxiety disorders. 3. History of severe neurological diseases, such as Parkinson’s disease, Alzheimer’s disease or other types of dementia, multiple sclerosis, epilepsy, etc. 4.Patients who have cardiac pacemakers, deep brain stimulators (DBS), vagus nerve stimulators (VNS), cochlear implants, aneurysm clips, or other intracranial metal implants implanted in their bodies. 5. Areas of the scalp where TIS electrodes are to be placed have active skin inflammation, damage, or infection; these areas are not suitable for electrode placement and electrical stimulation. 6. A history of drug dependence or alcohol abuse within the past year (according to DSM-5 criteria), or ongoing drug or alcohol abuse at the time of enrollment. 7. Pregnant or breastfeeding women. 8. Patients with severe or unstable medical conditions, such as uncontrolled severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg), severe heart failure (NYHA class III-IV), severe liver or kidney dysfunction (ALT/AST >2 times the upper limit of normal, or creatinine clearance <30 mL/min), or active malignant tumors. 9. Those who have previously received transcranial electrical stimulation therapy and experienced severe discomfort or adverse reactions, and are therefore unable to tolerate the treatment again. 10. Those with severe hearing or vision impairments, making it impossible to understand study instructions or complete assessments; or those with severe aphasia, preventing effective communication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index, PSQI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective sleep parameters; | — |
Countries
China
Contacts
Public ContactFeng Jinfa
Suzhou Municipal Hospital
Outcome results
None listed