Chronic Insomnia with Anxiety
Conditions
Interventions
Intervention Group:Transcranial electrical stimulator: stimulation parameters: 1. Carrier frequency f1=2 kHz, f2=2.13 kHz
2. Low-frequency envelope frequency ?f=f2? f1=130Hz
3. Current intensity I=2mA, current ratio 1:1
4. Stimulation duration: 30 minutes/time
5. Five consecutive days a week, Monday to Friday, once a day, a total of two weeks
6. The stimulation site was targeted to the sgACC brain area, and the electrode position was individually calculated according to the MRI results.
Control Group:Transcranial electrical stimulator: stimulation parameters: 1. Carrier frequency f1= 2kHz, f2=2kHz
2. Low-frequency envelope frequency ?f=f2? f1=0Hz
3. Current intensity I=0mA
6. Stimulation site: the sgACC brain region was targeted, and the electrode position was individually calculated according to the MRI results.
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects who can understand the contents of this study and sign the informed consent form. 2.Aged 18 to 65 years (inclusive of 18 and 65 years old), regardless of gender. 3.Diagnosed with chronic insomnia in accordance with the ICSD-3 diagnostic criteria by a attending physician or above at screening. 4.Duration of insomnia = 3 months. 5.Pittsburgh Sleep Quality Index (PSQI) score > 5. 6.Hamilton Anxiety Rating Scale (HAMA) score > 7 and <= 28. 7.No medication for insomnia prior to enrollment; or subjects who have maintained a stable dosage of medications for insomnia, depression and anxiety for at least 3 consecutive months before enrollment and will keep the dosage unchanged throughout the trial.
Exclusion criteria
Exclusion criteria: 1.Presence or history of other sleep disorders besides insomnia disorder, including sleep-related breathing disorders, central disorders of hypersomnolence, circadian rhythm sleep-wake disorders, parasomnias, and sleep-related movement disorders. 2.History of mental disorders other than anxiety and mild to moderate depression within 6 months prior to enrollment, including schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, obsessive-compulsive and related disorders, etc. 3.Hamilton Anxiety Rating Scale (HAMA) score > 29, and/or 17-item Hamilton Depression Rating Scale (HAMD-17) score > 24 at baseline screening. 4Moderate or severe cognitive impairment detected by Mini-Mental State Examination (MMSE), or Montreal Cognitive Assessment (MoCA) score < 22. 5.Pregnant women, lactating women, or women planning to conceive in the near future. 6.Severe systemic diseases involving the heart, lung, liver, kidney, thyroid and other major organs. 7.History of epileptic seizure, epilepsy, hydrocephalus, central nervous system tumors, acute brain injury or intracranial infection. 8.Secondary insomnia induced by specific etiologies, such as anemia, hyperthyroidism, shift work, etc. 9.Recent transmeridian travel or residence across 3 or more time zones within 2 weeks prior to enrollment. 10.Patients with anxiety or depression accompanied by suicidal ideation and/or psychotic symptoms. 11.Damaged skin integrity at electrode placement sites, or allergy to electrode gel or adhesive. 12.Implanted electronic stimulator devices. 13.History of modified electroconvulsive therapy (MECT) or transcranial magnetic stimulation (TMS) treatment. 14.Participation in any other clinical trial within 1 month prior to baseline assessment. 15.Regular alcohol consumption: females consuming more than 7 standard drinks per week, or males consuming more than 14 standard drinks per week. (1 standard drink = 5 fluid ounces (150 mL) of wine = 12 fluid ounces (360 mL) of beer = 1.5 fluid ounces (45 mL) of spirits) 16.Long-term benzodiazepine use or history of drug dependence/addiction. 17.Subjects deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The reduction rate of the total score of the Pittsburgh Sleep Quality Index (PSQI) at the end of the 2nd week of treatment compared with the baseline (within 1 week before the start of treatment); | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of insomnia severity;Assessment of anxiety severity; | — |
Countries
China
Contacts
Public ContactZhaoyang Huang
Xuanwu Hospital, Capital Medical University
Outcome results
None listed