A Multicenter Randomized Double-Blind Controlled Study on the Efficacy and Neural Mechanisms of Temporal Interference Stimulation for Insomnia Disorder

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Sham Stimulation Group:false stimulus;Real Stimulation Group:Temporal interference stimulation; CONDITION: Insomnia PRIMARY OUTCOME: Sleep Diary; SECONDARY OUTCOME: Objective Sleep Quality;Hyperarousal;Daytime Functioning and Mood Status;Neuroimaging Parameters;Cognitive Function;Adverse Events and Safety; INCLUSION CRITERIA: 1.Male and female subjects aged between 18 and 64 years (inclusive); 2.Body Mass Inde X(BMI) ranges from 18 to 30 kg/m² (inclusive of the boundary values); 3.Meet the diagnostic criteria for Insomnia Disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM‐5); 4.Insomnia Severity Inde X(ISI) total score >=15 points; 5.Subjective sleep onset latency (sSOL) >=30 minutes or subjective wake after sleep onset (sWASO) >=30 minutes on at least 3 nights per week, with subjective total sleep time (sTST) <6.5 hours; 6.During the month prior to screening and the trial period, the fluctuation range of habitual bedtime shall not exceed ±2 hours. 7.No medication administered in the past 4 weeks, or the original treatment regimen and dosage have been maintained stably for more than 4 weeks; 8.Good expected compliance, subjects will participate and sign the informed consent form;
Epistemonikos ID: 7575915b5300e5625978c3f526379bd549922480
First added on: Oct 08, 2026