A Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the Efficacy and Safety of Transcranial Light Stimulation for Chronic Insomnia

INTERVENTION: 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 day, with a 4‐hour interval between sessions. The second session was performed within 4 hours of bedtime. After 2 weeks of continuous treatment, the patient returned to the hospital for follow‐up after another 3 days of continuous use of the sleep monitor prior to the follow‐up visit.;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, with a 4‐hour interval between sessions. The second session was performed within 4 hours of bedtime. After 2 weeks of continuous treatment, a follow‐up visit was conducted again after another 3 days of continuous use of the sleep monitor prior to the 2‐week follow‐up.; CONDITION: Chronic Insomnia PRIMARY OUTCOME: Overall effective rate of treatment over a 2‐week period;Sleep Efficiency (SE) after 2 weeks of treatment; SECONDARY OUTCOME: 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); 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;