Treatment of Insomnia Using VR Glasses Combined with EEG Biofeedback Intelligent Meditation System

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Trial Group:Use of a VR‐based smart meditation system developed in this project, based on Pico4Pro VR headset (integrated with TGAM EEG module and wrist‐worn HRV sensor); integrating Mindfulness‐Based Cognitive Therapy (MBCT), Rational Emotive Behavior Therapy (REBT), Acceptance and Commitment Therapy (ACT), and biofeedback technology; three times per week, 45 minutes per session, for 8 weeks (total 24 sessions); real‐time monitoring of prefrontal a/ß/? waves and HRV indicators, with automatic adjustment of breathing guidance or virtual scenario difficulty based on user's physiological state (e.g., distraction or anxiety).;Control Group:Face‐to‐face traditional Cognitive Behavioral Therapy for Insomnia (CBT‐I) conducted by psychologists trained uniformly; including standard modules such as sleep hygiene education, sleep restriction therapy, cognitive restructuring, and relaxation training; three times per week, 45 minutes per session, for 8 weeks (total 24 sessions); no use of any VR or biofeedback devices.; CONDITION: Insomnia PRIMARY OUTCOME: Change in Pittsburgh Sleep Quality Index (PSQI) Total Score; SECONDARY OUTCOME: Insomnia Severity Inde X(ISI) Score;Reduction Rate of Hamilton Anxiety Rating Scale (HAM‐A);Objective Physiological Parameters of Heart Rate Variability (HRV) (RMSSD, LF/HF Ratio); INCLUSION CRITERIA: 1. Aged 18‐65 years old; 2. Diagnosed with insomnia according to DSM‐5 and with a GAD‐7 score >5; 3. PSQI score >5; 4. Signed the informed consent form; 5. Able to understand and follow the research procedure.
Epistemonikos ID: a2622a4aee69a2b4ca7017ff351a770ddc87d9b3
First added on: May 02, 2026