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

NCT06443242 | Not Yet Recruiting DMC

• 1 other identifier: XYEFYLL-(Research)-2024-36
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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. 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. 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.

Conditions

Major Depressive Disorder; Insomnia

Outcome Measures

Primary Outcomes (1)

• 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

  This outcome measure evaluates the change in sleep quality in patients with major depressive disorder (MDD) and insomnia treated with Low-Dose Laser Acupuncture (LLA). The Pittsburgh Sleep Quality Index (PSQI) is used, with scores ranging from 0 to 21, where higher scores indicate poorer sleep quality.

  Pre-treatment, immediately post-treatment and 12 weeks post-treatment.

Secondary Outcomes (8)

• 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)

Study Arms (3)

Low-Dose Laser Acupuncture (LLA) Group

EXPERIMENTAL

In the Low-Dose Laser Acupuncture (LLA) group, participants receive treatments using the xS-998D06 semiconductor laser acupoint therapeutic device from Nanjing Xiaosong Medical Instruments. This device operates at a wavelength of 780 nm and an output power of 5 mW. Each 20-minute session involves securing the device's probe to specific acupoints (Baihui, Yintang, Anmian, Shenmen, Neiguan, Sanyinjiao, and Taichong) using medical tape. Treatments occur daily for 5 consecutive days each week, with a two-day break, over a 6-week period. All participants, regardless of group assignment, will maintain their regular antidepressant regimen (patients with only one type of antidepressant, such as selective serotonin reuptake inhibitor \[SSRI\] or serotonin noradrenaline reuptake inhibitor \[SNRI\] or mirtazapine).

Device: Low-Dose Laser Acupuncture (LLA)

Sham Laser Acupuncture (SLA) Group

SHAM COMPARATOR

Participants in the Sham Laser Acupuncture (SLA) group undergo a sham treatment involving the same procedure and acupoint targeting as the LLA group. The difference lies in the instrument probe being fixed to the acupoint but emitting a dummy laser, simulating the acupuncture experience without actual laser emission. All participants, regardless of group assignment, will maintain their regular antidepressant regimen (patients with only one type of antidepressant, such as selective serotonin reuptake inhibitor \[SSRI\] or serotonin noradrenaline reuptake inhibitor \[SNRI\] or mirtazapine).

Device: Sham Laser Acupuncture (SLA)

Control Group

NO INTERVENTION

The control group, which serves as a non-intervention comparison, will continue their standard treatment regimen (patients with only one type of antidepressant, such as selective serotonin reuptake inhibitor \[SSRI\] or serotonin noradrenaline reuptake inhibitor \[SNRI\] or mirtazapine).

Interventions

Low-Dose Laser Acupuncture (LLA) DEVICE

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.

Low-Dose Laser Acupuncture (LLA) Group

Sham Laser Acupuncture (SLA) DEVICE

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.

Sham Laser Acupuncture (SLA) Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Inpatients with a diagnosis of major depressive disorder (diagnosed according to the relevant diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders-V).
• Male or female, 18 to 60 years of age.
• Participants complaining of insomnia at initial screening.
• PSQI score over 7.
• HAMD score between 20 and 35.
• No use of hypnotic medication or acupuncture treatment within the last month.
• No cognitive or communication disorders.
• Willingness to accept random group assignment and sign an informed consent form.
• Those who have been on stable dose of antidepressant for at least the most recent two weeks and willing to maintain on the same dosage throughout the study.

You may not qualify if:

• Individuals with a marked tendency towards suicide, as assessed by a specialist;
• Individuals previously diagnosed with schizophrenia, bipolar disorder, or other psychiatric disorders;
• Individuals with severe alcohol or drug abuse issues;
• Individuals with liver or kidney dysfunction, or with uncontrollable tumors or significant cerebrovascular diseases;
• Women who are pregnant or breastfeeding;
• Individuals likely to have poor compliance or who are fearful of acupuncture treatment.

Sponsors & Collaborators

• Mohammad Farris Iman Leong Bin Abdullah: lead
• Xinxiang medical university: collaborator

Related Publications (1)

• Qiu Q, Yam MF, Yang W, Guo F, Liu C, Leong Bin Abdullah MFI, Yang S. Efficacy and safety of laser acupuncture for treating insomnia in major depressive disorder: study protocol for a randomized controlled trial. Front Psychiatry. 2025 Nov 20;16:1698773. doi: 10.3389/fpsyt.2025.1698773. eCollection 2025.

  PMID: 41356687 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: June 5, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be uploaded in Figshare data repository after completion of the study and it will be available for 2 years after completion of the study.
• Access Criteria: All researchers and study participants upon request after completion of the study.