NCT06443242

Efficacy and Safety of Low-dose Laser Acupuncture on Treating Insomnia Associated With Major Depressive Disorder

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Mohammad Farris Iman Leong Bin Abdullah · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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 elements, the study aims to provide clear, actionable insights into the benefits and risks of LLA as a treatment option for insomnia associated with major depressive disorder, enhancing the current treatment landscape and patient outcomes.

Detailed description

This randomised controlled trial aims to explore the therapeutic potential of low-dose laser acupuncture (LLA) for treating insomnia in patients diagnosed with major depressive disorder. The study will investigate the physiological and psychological impacts of LLA in comparison with sham laser acupuncture (SLA) and standard pharmacological therapies. Intervention Details: LLA involves the application of a low-level laser to specific acupoints known to affect sleep and mood regulation. The technique mimics traditional acupuncture but uses laser light to stimulate these points without physical penetration of the skin, offering a non-invasive alternative with potentially fewer adverse effects. The primary acupoints targeted in this study include Baihui (GV20), Yintang (GV29), Anmian (EX-HN22), Shenmen (HT7), Neiguan (PC6), Sanyinjiao (SP6), and Taichong (LR3). Study Phases: The study will be structured into three key phases: pre-treatment, immediately post-treatment, and 12 weeks post-treatment. During the pre-treatment phase, baseline evaluations will be conducted to establish initial levels of insomnia and depressive symptoms in participants. The treatment phase will follow, lasting six weeks, with participants receiving five sessions per week. Subsequent assessments will occur immediately post-treatment to evaluate the immediate effects of the interventions, and again at 12 weeks post-treatment to assess the long-term outcomes. Research Focus: The study will particularly focus on the effectiveness of LLA in improving sleep quality as measured by validated scales and objective assessments like actigraphy, which monitors sleep-wake patterns. Additionally, the research will assess changes in psychological state and biochemical markers, which are critical in understanding the interaction between sleep disorders and depression. These measures will help ascertain whether LLA can alter the physiological pathways typically disrupted in major depressive disorder, potentially offering a new avenue for treatment that could complement or reduce the need for pharmacological intervention. Innovation and Potential Impact: By integrating a novel, non-invasive method such as LLA, the study could significantly impact the treatment strategies for insomnia in the context of major depressive disorder. This approach not only aims to reduce symptoms but also to enhance overall treatment tolerance and patient adherence, addressing key challenges in managing these interlinked conditions.

Conditions

• Major Depressive Disorder
• Insomnia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-08-31
• Completion: 2027-08-31
• First posted: 2024-06-05
• Last updated: 2025-09-10