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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06443242
• Other study ID #: XYEFYLL-(Research)-2024-36
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: September 1, 2027

Study information

• Verified date: May 2024
• Source: Universiti Sains Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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?

3. Does LLA enhance the effectiveness of pharmacological interventions in treating insomnia and major depressive disorder when used as an adjunctive treatment?

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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. 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).

2. Male or female, 18 to 60 years of age.

3. Participants complaining of insomnia at initial screening.

4. PSQI score over 7.

5. HAMD score between 20 and 35.

6. No use of hypnotic medication or acupuncture treatment within the last month.

7. No cognitive or communication disorders.

8. Willingness to accept random group assignment and sign an informed consent form.

9. 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.

Exclusion Criteria:

1. Individuals with a marked tendency towards suicide, as assessed by a specialist;

2. Individuals previously diagnosed with schizophrenia, bipolar disorder, or other psychiatric disorders;

3. Individuals with severe alcohol or drug abuse issues;

4. Individuals with liver or kidney dysfunction, or with uncontrollable tumors or significant cerebrovascular diseases;

5. Women who are pregnant or breastfeeding;

6. Individuals likely to have poor compliance or who are fearful of acupuncture treatment.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Insomnia
• Major Depressive Disorder
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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.

Drug:
• Standard Medication Management (Control Group)
This intervention involves the continued use of standard pharmacological treatment with SSRIs for managing symptoms of depression. It serves as a control to evaluate the effects of laser acupuncture against conventional medical treatment without the introduction of additional therapeutic modalities. Participants' adherence to their prescribed medication regimen is monitored and documented, ensuring an accurate comparison of treatment effects across groups.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mohammad Farris Iman Leong Bin Abdullah

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)	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.
Primary	Change in Insomnia Severity Assessed by Insomnia Severity Index (ISI)	This outcome measure assesses the change in insomnia severity in patients with MDD and insomnia treated with LLA. The Insomnia Severity Index (ISI) is used, with scores ranging from 0 to 28, where higher scores indicate more severe insomnia.	Pre-treatment, immediately post-treatment and 12 weeks post-treatment.
Primary	Objective Sleep Patterns Assessed by Actigraphy	This outcome measure evaluates the change in objective sleep patterns in patients with MDD and insomnia treated with LLA. Actigraphy provides data on sleep parameters such as total sleep time, sleep efficiency, and number of awakenings.	Pre-treatment, immediately post-treatment and 12 weeks post-treatment.
Secondary	Severity of Depressive Symptoms Assessed by Hamilton Depression Rating Scale (HAMD)	This outcome measure evaluates the impact of LLA on the severity of depressive symptoms in patients with MDD and insomnia. The Hamilton Depression Rating Scale (HAMD) is used, with scores ranging from 0 to 52, where higher scores indicate more severe depression symptoms.	Pre-treatment, immediately post-treatment and 12 weeks post-treatment.
Secondary	Severity of Anxiety Symptoms Assessed by Self-Rating Anxiety Scale (SAS)	This outcome measure evaluates the impact of LLA on the severity of anxiety symptoms in patients with MDD and insomnia. The Self-Rating Anxiety Scale (SAS) is used, with scores ranging from 20 to 80, where higher scores indicate more severe anxiety symptoms.	Pre-treatment, immediately post-treatment and 12 weeks post-treatment.
Secondary	Serum Corticosterone Levels	This outcome measure examines the change in serum corticosterone levels in patients with MDD and insomnia treated with LLA. Corticosterone levels are measured in ng/mL, with higher levels typically associated with higher stress and worse outcomes.	Pre-treatment, immediately post-treatment and 12 weeks post-treatment.
Secondary	Serum 5-Hydroxytryptamine (5-HT) Levels	This outcome measure examines the change in serum 5-hydroxytryptamine (5-HT) levels in patients with MDD and insomnia treated with LLA. 5-HT levels are measured in ng/mL, with lower levels typically associated with worse outcomes in depression and insomnia.	Pre-treatment, immediately post-treatment and 12 weeks post-treatment.
Secondary	Incidence of Treatment-Emergent Adverse Events	This outcome measure assesses the incidence of treatment-emergent adverse events to determine the safety of LLA. It compares the dropout rates due to adverse effects among patients in the LLA, Sham Laser Acupuncture (SLA), and control groups.	Throughout the study duration (Pre-treatment through 12 weeks post-intervention)