Wearable low-level laser therapy (laser acupuncture) versus manual acupuncture for chronic insomnia: protocol for a randomized, assessor-blinded, superiority trial.

Background: Chronic insomnia is a prevalent and disabling condition associated with impaired daytime functioning, psychiatric comorbidity, and autonomic dysregulation. Although cognitive behavioral therapy for insomnia (CBT-I) is recommended as the first-line treatment, access is limited. Acupuncture has demonstrated therapeutic benefits for insomnia but requires trained practitioners and repeated clinic visits. Low-level laser therapy (LLLT), an acupoint-targeted form of photobiomodulation that is also referred to as laser acupuncture when applied to acupuncture points, offers a non-invasive and standardized modality that may serve as a practical alternative. Methods: This single-center, parallel-group, assessor-blinded, superiority randomized controlled trial will compare wearable LLLT with manual acupuncture in 106 adults with chronic insomnia. Participants aged 18-65 years who meet DSM-5 criteria for chronic insomnia and have an Insomnia Severity Index (ISI) score between 8 and 21 will be randomly allocated (1:1) to the LLLT group or acupuncture group. Both interventions will target bilateral HT7, PC6 and SP6 (six acupoints in total) for 30 minutes per session, three times per week, over two weeks (six sessions total). In the LLLT group, 650-nm laser irradiation will be delivered simultaneously to all six acupoints. The primary outcome is the change in ISI score from baseline to week 2. Secondary outcomes include sleep quality (Pittsburgh Sleep Quality Index, PSQI), fatigue (Fatigue Severity Scale, FSS), depressive symptoms (Patient Health Questionnaire-9, PHQ-9), anxiety (Generalized Anxiety Disorder-7, GAD-7) and heart rate variability (HRV) indices. The ISI will be assessed at baseline, post-treatment (week 2), and follow-up (week 6). Secondary outcomes, including PSQI, FSS, PHQ-9, GAD-7, and HRV indices, will be assessed at baseline and week 2. Analyses will follow the intention-to-treat principle using analysis of covariance and prespecified longitudinal or repeated-measures models where appropriate. Discussion: This trial will provide comparative evidence on the short-term efficacy and safety of wearable LLLT versus manual acupuncture for chronic insomnia. By directly comparing an established acupuncture protocol with a non-invasive intervention that has potential for future home-based implementation, the study aims to clarify the clinical value of LLLT as a less invasive alternative within the framework of complementary and integrative sleep medicine. Clinical trial registration: https://itmctr.ccebtcm.org.cn/Home/ProjectView?pid=d0e46c39-0647-4cbd-ba40-e2b02830fd28, identifier ITMCTR2025000977.