Efficacy and Safety of Low-dose Laser Acupuncture on Treating Insomnia Associated With Major Depressive Disorder: A Randomised Controlled Trial

Official Summary

The goal of this randomized controlled trial is to assess the efficacy and safety of low-dose laser acupuncture (LLA) in alleviating insomnia symptoms among patients suffering from major depressive disorder. The study seeks to answer the following questions: 1. How effective is LLA in alleviating insomnia symptoms as compare with SLA and control subjects among patients with major depressive disorder across pre-treatment, mid-treatment and post-treatment assessment? 2. How effective is LLA in alleviating depression symptoms as compare with SLA and control subjects among patients with major depressive disorder across pre-treatment, post-treatment and follow-up assessment? 3. What role do CORT and 5-HT play in the co-occurrence and progression of insomnia and major depressive disorder, and how does LLA act on these mechanisms to provide relief? 4. How does the safety and acceptability of LLA compare to traditional acupuncture in terms of eliminating discomfort and potential side effects? Researchers will compare the effects of LLA with sham laser acupuncture (SLA) and standard medication treatments to evaluate its efficacy and safety. Participants involved in this study will: Undergo 30 treatment sessions with LLA or SLA, five times a week for six weeks. Continue their usual pharmacological treatments for major depressive disorder. Participants will undergo comprehensive assessments at key points: pre-treatment, immediately post-treatment, and 12 weeks post-treatment. These evaluations will measure sleep quality and severity of insomnia indices, levels of depression and anxiety, and blood levels of CORT and 5-HT to assess the impact of LLA on insomnia symptoms and biochemical markers. Additionally, participant acceptance and the safety of the treatment will be monitored, including recording any adverse events and medication usage, to determine the effectiveness and safety of LLA in treating insomnia associated with major depressive disorder. By focusing on these e

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 120 participants

Interventions

• DEVICE: Low-Dose Laser Acupuncture (LLA) — The intervention utilizes the xS-998D06 semiconductor laser acupoint therapeutic device specifically designed for targeted acupoint therapy. This device is critical in delivering precise low-dose laser therapy at a controlled wavelength and power. The laser treatment is directed towards enhancing neurological function and potentially alleviating symptoms of insomnia and depression by stimulating specific acupoints associated with mental health and sleep.
• DEVICE: Sham Laser Acupuncture (SLA) — Sham laser acupuncture serves as a control to assess the placebo effect of the laser treatment. It involves the same procedure as LLA but uses a non-emitting laser probe. This intervention is designed to mimic the LLA setup without delivering actual laser therapy, allowing for an evaluation of the psychological and physiological effects of the placebo compared to the active laser treatment.

Primary Outcomes

• Change in sleep quality from pre-treatment assessed by the Pittsburgh Sleep Quality Index (PSQI) score at immediately post-treatment and 12 weeks post-treatment (Pre-treatment, immediately post-treatment and 12 weeks post-treatment.)

Secondary Outcomes

• Changes in severity of depressive symptoms from pre-treatment assessed by Hamilton Depression Rating Scale (HAMD) score at immediately post-treatment and 12 weeks post-treatment (Pre-treatment, immediately post-treatment and 12 weeks post-treatment.)
• Changes in severity of insomnia from pre-treatment measure by Insomnia Severity Index (ISI) score at immediately post-treatment and 12 weeks post-treatment (Pre-treatment, immediately post-treatment and 12 weeks post-treatment)
• Changes in serum corticosterone levels from pre-treatment measure by Immunoassays at immediately post-treatment and 12 weeks post-treatment (Pre-treatment, immediately post-treatment and 12 weeks post-treatment.)
• Changes in serum 5-Hydroxytryptamine (5-HT) levels from pre-treatment measure with Enzyme-Linked Immunosorbent Assay at immediately post-treatment and 12 weeks post-treatment (Pre-treatment, immediately post-treatment and 12 weeks post-treatment.)
• Changes in the incidence of treatment-emergent adverse events from pre-treatment assess as dropout rates at immediately post-treatment and 12 weeks post-treatment (Throughout the study duration (Pre-treatment through 12 weeks post-intervention))

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