Skip to content

Study of brain aging degree and transcranial direct current stimulation intervention for patients with chronic insomnia based on EEG

Study of brain aging degree and transcranial direct current stimulation intervention for patients with chronic insomnia based on EEG

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047548
Enrollment
Unknown
Registered
2021-06-20
Start date
2021-06-15
Completion date
Unknown
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic insomnia

Interventions

Experimental 2 group:Transcranial direct current pseudo stimulation
Control group:None

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients with chronic insomnia: 1.Met the DSM-V diagnosis of chronic insomnia, with more than 3 sleep disorders per week and a disease course of more than 3 months; 2.PSQI > 7 (8-21); 3.Aged 18 to 80 years; 4.Subjects have more than 6 years of education and are capable of completing the cognitive function measurement and other tests required by the protocol; 5.Signed the informed consent; 6.Right-handed. Control group: 1.No complaints of sleep quality or quantity; 2.PSQI 7 points or less; 3.Aged 18 to 80 years; 4.Subjects have more than 6 years of education and are capable of completing the cognitive function measurement and other tests required by the protocol; 5.Signed the informed consent; 6.Right-handed.

Exclusion criteria

Exclusion criteria: 1.Physical diseases such as chronic pain and other sleep disorders (such as sleep apnea syndrome, restless leg syndrome, periodic limb movement, REM sleep disorders, etc.); 2.Patients with schizophrenia, bipolar disorder, delirium and other psychiatric disorders who meet DSM-IV criteria; 3.Previous alcohol and drug dependence or abuse; 4.Patients suffer from severe or unstable organic diseases (including severe heart, liver and kidney diseases, tumors, etc.); 5 Meeting the diagnostic criteria of depression and anxiety, Hamilton Depression Scale (HAMD) (17 items) >17 points, Hamilton Anxiety Scale (HAMA) >14 points; 6.Patients diagnosed with dementia at baseline (e.g., Alzheimer's disease, Parkinson's disease, dementia with lewy body, frontotemporal dementia); 7.A clear history of cerebrovascular stroke, clear symptoms and signs of neurological impairment at the onset, and corresponding responsible lesions left by neuroimaging; 8.Brain trauma, epilepsy, encephalitis, hydrocephalus, brain tumors and other neurological diseases that can cause cognitive impairment; 9.Severe insufficiency of liver and kidney, endocrine diseases, and cognitive dysfunction caused by vitamin deficiency. Abnormal laboratory indicators: 10.Moderate anemia, fasting blood glucose more than 2 times the upper limit of normal, CR more than 1.5 times the upper limit of normal, liver function (AST or ALT) more than 2 times the upper limit of normal; 11.Sleep disorders caused by jet lag and shift work; 12.During screening, systolic blood pressure > 180mmHg or 120mmHg or < 60mmHg; 13.Take cognitive-improving drugs, such as donepezil, galantamine, cabalatin, memantine, etc.; take drugs that have negative effects on cognitive function, such as anticholinergic drugs, antipsychotics, antiepileptic drugs, hormones, etc.; 14.Having implantable electronic devices (such as implanted pacemakers); 15.Intracranial metal implants.

Design outcomes

Primary

MeasureTime frame
Resting state EEG and event-related potentials;Montreal Cognitive Behavior Scale;The Pittsburgh Sleep Quality Index;

Secondary

MeasureTime frame
Auditory Verbal Learning Test;Boston named test;Wechsler Adult Intelligence Scale Number Span Test;Trail making test;Mini-mental state examination;Verbal fluency test;Functional activities questionnaire;Hamilton's Depression Scale;Hamilton anxiety scale;Sleep related parameters;Insomnia severity Index scale;Epworth sleepiness score;Sleep Beliefs and Attitudes Scale (Simplified DBAS-16);

Countries

China

Contacts

Public ContactBian Zhijie

Beijing Friendship Hospital, Capital Medical University

bzj2014win@163.com+86 13366988769

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026