Insomnia
Conditions
Interventions
Control group:Sham stimulation
Intervention group:The stimulation intensity is 100% of the resting motor threshold (RMT). The total treatment course consists of 16 sessions over a 4 - week period (in the first 2 weeks: 5 sessions p
in the last 2 weeks: 3 sessions per week). First, 1Hz stimulation is applied to the right dorsolateral prefrontal cortex for 20 minutes continuously, with a total of 1200 stimuli. Then, 10Hz stimulati
Sponsors
Weihai Municipal Hospital of Shandong Province
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 40 and 80 years old, regardless of gender. 2.Chronic insomnia: Sleep disturbances and related daytime symptoms occur at least 3 times a week and persist for at least 3 months. Sleep disturbances (>=1 symptom): Difficulty initiating sleep; Difficulty maintaining sleep; Waking up earlier than expected; Reluctance to go to bed at an appropriate bedtime; Difficulty falling asleep without parental or caregiver intervention. Daytime symptoms (>=1 symptom): Fatigue, discomfort; Impaired attention or memory; Impaired social, household, occupational or academic abilities; Emotional disturbance/irritability; Daytime drowsiness; Behavioral problems, such as hyperactivity, impulsivity, aggression; Decreased motivation, energy, and work initiative; Prone to errors and accidents; Concern or dissatisfaction with sleep. 3.Complaint of memory impairment (within 6 months). 4.The patient is conscious and can cooperate to complete examinations, questionnaires, medical history collection, etc., either independently or with the help of family members. 5.Agree to participate in this study and sign the informed consent form..
Exclusion criteria
Exclusion criteria: 1.Other sleep disorders: environmental sleep difficulties, sleep - disordered breathing, restless legs syndrome, sleep - wake rhythm disorders, parasomnias, sleep movement disorders. 2.Previously diagnosed with dementia (such as Alzheimer's disease, vascular dementia, Lewy body dementia, etc.) and those whose MMSE scores can diagnose dementia (for illiterate participants, MMSE score < 17; for participants with primary education, MMSE < 20; for participants with junior high school education or above, MMSE < 24). 3.Neurological diseases (brain tumors, cerebrovascular diseases, epilepsy, movement - disorder diseases, previous brain surgeries), mental system diseases (schizophrenia, paranoid psychosis, severely impaired social function). 4.Major unstable diseases that require further examination or treatment. 5.Those who have taken sleep - aiding medications in the past two weeks or have previously received TMS treatment. 6.Contraindications for repetitive transcranial magnetic stimulation, such as hair style obstructing the placement of closed coils, perforation. 7.Current substance abuse or dependence (DSM - 5 criteria: intake exceeds expectations; craving or attempts to control the dosage; spending a lot of time trying to obtain the substance, giving up social, work or recreational activities due to using the substance; continuing to use the substance despite knowing that it can cause or worsen physical or psychological problems). 8.Pregnant or lactating women. 9.Those who are unwilling to be followed up or have poor treatment compliance. 10.Those who are currently participating in other clinical trials or have participated in other clinical trials within 3 months before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia condition; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive function;The situation of depression ;Anxiety situation; | — |
Countries
China
Contacts
Public ContactZhang Jinbiao
Weihai Municipal Hospital
Outcome results
None listed