Chronic Insomnia
Conditions
Interventions
Experimental group:On the day of patient enrollment, the sleep monitor was used before sleep. After continuous use for 3 days, the treatment device was started, with 30 minutes per session, twice a da
Control group:On the day of patient enrollment, the sleep monitor was used before sleep. After continuous use for 3 days, the treatment device was started, with 20 minutes per session, twice a day, wi
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 70 years (with a threshold value), male and female; 2.Compliance with the diagnostic criteria for chronic insomnia in the International Classification of Sleep Disorders III (ICSD-3). The diagnostic criteria are as follows, and criteria A to F must be met: A. The patient reports, or the patient's parents or caregiver observes, one or more of the following: (1) difficulty falling asleep; (2) Sleep maintenance difficulties; (3) wake up earlier than expected; (4) refuse to go to bed at the appropriate time; (5) It is difficult to fall asleep without parental or caregiver intervention; B. The patient reported, or the patient's parents or caregivers observed, that the patient had one or more of the following factors associated with difficulty sleeping at night: (1) fatigue or malaise; (2) Attention, concentration or memory decline; (3) impairment of social, family, occupational or academic functions; (4) emotionally unstable or irritable; (5) Doze during the day; (6) behavioural problems (e.g. excessive activity, impulsiveness, or aggression); (7) Decrease in motivation, energy or work initiative; (8) prone to mistakes or accidents; (9) Are very concerned or dissatisfied with the quality of your sleep; C. These sleep / wakefulness complaints cannot be entirely explained by inappropriate sleep opportunities (e.g., adequate sleep time) or environments (e.g., dark, quiet, safe, comfortable environments); D. These sleep difficulties and associated daytime symptoms occur at least 3 times per week; E. These sleep difficulties and associated daytime symptoms persist for at least 3 months; F. These sleep difficulties and associated daytime symptoms are not better explained by other sleep disorders; 3.Pittsburgh Sleep Quality Index Scale (PSQI) score > 7 ; 4.Participants had not used anti-insomnia medications (calming hypnosis, anti-epileptic, anti-depressant, anti-anxiety, central analgesic, antihistamine H1 receptor drugs) in the 14 days prior to screening; 5.Be willing to participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals with phototoxic disorders; 2.Patients with brain tumors or other brain organic diseases, those who have undergone brain trauma surgery, and those with unhealed injuries; cerebral infarction (excluding lacunar infarction); 3.Temporary insomnia caused by temporary emotional stress or noisy environments, discomfort while lying down, or consumption of coffee, strong tea, alcohol before bed; 4.Insomnia resulting from physical illnesses such as fever, cough, pain, or the use of central excitatory medications; 5.Pregnant or breastfeeding women; 6.Patients with clinically confirmed malignant tumors (e.g., lung cancer, stomach cancer, breast cancer, liver cancer, fibrosarcoma, liposarcoma, lymphoma); 7.Individuals with mental disorders or cognitive impairments, unable to communicate normally; 8.Patients in a state of severe anxiety (7-item Generalized Anxiety Disorder Scale score >= 15); 9.Patients in a state of severe depression (9-item Patient Health Questionnaire score >= 20); 10.Patients with irregular lifestyles or those who cannot adhere to the required regimen for device wear; 11.Individuals with implanted electronic devices; 12.Patients deemed unsuitable by the researchers for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall effective rate of treatment over a 2-week period;Sleep Efficiency (SE) after 2 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the sleep onset latency (SOL);Changes in sleep efficiency (SE);Changes in total sleep time (TST);Changes in the time to awaken after falling asleep (WASO);Changes in the frequency of awakenings;Changes in the duration of N3;Changes in the duration of REM sleep;Changes in scores on the Generalized Anxiety Disorder 7-item scale (GAD-7);Changes in scores from the 9-item Patient Health Questionnaire (PHQ-9); | — |
Countries
China
Contacts
Public ContactZhao Dong
Chinese PLA General Hospital
Outcome results
None listed