insomnia
Conditions
Interventions
Experiment group:TMS therapy
Control group:CES+music therapy
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age range between 18 and 60 at the time of signing the informed consent form; 2.Dissatisfied with the original basic treatment, and meeting the criteria for insomnia disorders in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). 3.sSOL >= 30 minutes within 45-75 minutes and ISI score of 8-21 (mild to moderate insomnia) on at least 3 nights per week during the 4 weeks prior to the start of the trial; 4. Self-reported regular bed time (sleeping or trying to fall asleep) is 7-9 hours; 5. According to the answers in the sleep diary of the last 7 mornings before the screening period(i.e. SOL >= 30 minutes on at least 3 of the 7 nights), the current insomnia symptoms were confirmed; 6. According to the answers in the sleep diary of the last 7 mornings before the visit (e.g. bed rest duration 10 hours for no more than 2 nights), it is confirmed that there is enough bed rest time; 7. The objective (Huawei bracelet) evidence of insomnia in the last seven days before the visit is as follows: SOL >= 30 minutes on two consecutive nights or more than three nights and SOL is not less than 20 minutes on two nights; 8. The subject is willing and able to comply with all aspects of the protocol, including the time of staying in bed >= 7 hours per night; 9. During the study period, the subject agree not to use new drugs therapy or other physical therapy.
Exclusion criteria
Exclusion criteria: 1. Medical or psychiatric history that the investigator believes could affect the safety of the subject or interfere with study evaluation. 2. Planned or unplanned suicidal thoughts at the time of screening or within 6 months of screening. 3. Any suicidal behavior in the past 10 years. 4. Clinically significant diseases (e.g. heart disease, respiratory diseases, including chronic obstructive pulmonary disease, acute and/or severe respiratory depression); Gastrointestinal diseases; Severe liver damage; Kidney disease, including moderate and/or severe kidney damage; Neurological disorders, including myasthenia gravis; Mental illness; Or a history of malignancy within the past 5 years, other than adequately treated basal cell carcinoma) or chronic pain that the investigators believe may affect the safety of the subjects or interfere with study evaluation. Subjects whose sedatives are prohibited for safety reasons due to the subject's occupation or activity are also excluded. Surgery is planned during the study. 5. A history of drug or alcohol dependence or abuse within the last 2 years or so. 6. Currently diagnosed sleep-related breathing disorders include obstructive sleep apnea (with or without continuous positive airway pressure (CPAP) therapy), periodic limb movement disorders, restless leg syndrome, circadian rhythm sleep disorders, or narcolepsy. 7. Report a history of violent sleep-related behavior, or sleep driving, or any other complex sleep-related behavior (e.g., talking on the phone or preparing food and eating while asleep). 8. Habitually naps more than three times a week during the day. 9. Researchers believe that excessive caffeine caused the subjects to suffer from insomnia, or habitually consume caffeinated beverages after 18:00, and were unwilling to refuse caffeine after 18:00 during the study period. Exclude subjects whose symptoms meet DSM-5 criteria for caffeine intoxication within the last 3 months, including consumption of large amounts of caffeine (significantly more than 250 mg), and who have =5 of the following symptoms: Restlessness, nervousness, excitement, insomnia, facial flushing, polyuria, gastrointestinal disorders, muscle twitching, lack of thought and speech, tachycardia or arrhythmia, energetic or psychomotor agitation. To be exclusive, these conditions must cause social, occupational, or other functional disturbance or impairment and are not associated with other substances, mental disorders, or medical conditions. 10. Reported habitual consumption of more than 14 alcoholic beverages per week (women) or more than 21 alcoholic beverages per week (men), or an unwillingness to limit alcohol intake during study participation (no more than 2 drinks per day, or no alcohol consumed within 3 hours before bedtime). 11. Rule out comorbidity nocturia, which can cause or aggravate insomnia. 12.Inter-time zone travel across more than 3 time zones in the 2 weeks prior to screening or between screening and baseline, or planning to travel through more than 3 time zones during the study(Mainland China will be considered as 1 time zone). 13.Having a positive drug test result at screening, introduction or baseline, or being unwilling to give up recreational drug use during the study period. 14. Participating in another clinical trial or using any investigational drug or device within 30 days prior to signing the informed consent. Women who were lactating or pregnant at the time of screening or baseline (as demonstrated b
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep Latency, SOL; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total sleep time, TST;Sleep efficiency, SE;Sleep Quality ; | — |
Countries
China
Contacts
Public ContactLv Yudan
The First Hospital of Jilin University
Outcome results
None listed