Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443242
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-13
Brief Title:
Efficacy and Safety of Low-dose Laser Acupuncture on Treating Insomnia Associated With Major Depressive Disorder
Sponsor:
Mohammad Farris Iman Leong Bin Abdullah
Organization:
Universiti Sains Malaysia
Study Overview
Official Title:
Efficacy and Safety of Low-dose Laser Acupuncture on Treating Insomnia Associated With Major Depressive Disorder A Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None