Data Sheet 2_Efficacy and safety of laser acupuncture for treating insomnia in major depressive disorder: study protocol for a randomized controlled trial.pdf

BackgroundEffective options for managing insomnia in major depressive disorder (MDD) remain limited. This randomized, single-blind, three-arm parallel trial will compare low-dose laser acupuncture (LA), sham laser acupuncture (SLA), and standard care, evaluating changes in sleep and mood alongside serum biomarkers at three time points (t0 = pre-treatment; t1 = post-treatment, 6 weeks; t2 = follow-up, 12 weeks after treatment).
MethodsA total of 120 inpatients meeting all eligibility criteria will be randomized (1:1:1) to LA, SLA, or control. The primary outcome is the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes include the Insomnia Severity Index (ISI), the 17-item Hamilton Depression Rating Scale (HAMD-17), serum 5-hydroxytryptamine (5-HT) and cortisol (CORT), and actigraphy. Outcomes are assessed at t0, t1, and t2. Safety will be evaluated by adverse events (AEs) and discontinuations due to adverse effects. Analyses will follow the intention-to-treat principle.
DiscussionBy integrating validated clinical endpoints with biomarker assessments, this trial will provide rigorous evidence on the efficacy and safety of low-dose LA for insomnia comorbid with MDD and help clarify potential mechanisms of action. If effective, LA could offer a non-invasive adjunct or alternative to current therapies.
Registration DetailsClinicalTrials.gov, identifier NCT06443242.

背景 目前针对重度抑郁症（Major Depressive Disorder, MDD）伴发失眠的有效管理手段仍较为匮乏。本项随机、单盲、三臂平行对照试验将比较低剂量激光针灸（low-dose laser acupuncture, LA）、假激光针灸（sham laser acupuncture, SLA）与标准治疗方案，在三个时间节点（t0=治疗前；t1=治疗后6周；t2=治疗后12周随访）评估受试者睡眠与情绪的变化，同时检测血清生物标志物水平。
方法 共计120名符合全部入组标准的住院患者将按照1:1:1的比例随机分配至LA组、SLA组与对照组。本试验的主要结局指标为匹兹堡睡眠质量指数（Pittsburgh Sleep Quality Index, PSQI）；次要结局指标包括失眠严重指数量表（Insomnia Severity Index, ISI）、17项汉密尔顿抑郁评定量表（17-item Hamilton Depression Rating Scale, HAMD-17）、血清5-羟色胺（5-hydroxytryptamine, 5-HT）与皮质醇（cortisol, CORT）水平，以及体动记录仪检测结果。所有结局指标均在t0、t1、t2三个时间点进行评估。安全性将通过不良事件（adverse events, AEs）及因不良反应退出试验的情况进行评价。数据分析将遵循意向性治疗原则。
讨论 本试验将经过验证的临床终点指标与生物标志物检测相结合，为低剂量LA治疗MDD伴发失眠的有效性与安全性提供严谨的循证依据，并有助于阐明其潜在的作用机制。若证实有效，LA可为现有治疗方案提供一种无创的辅助手段或替代选择。
注册信息 本试验已在ClinicalTrials.gov注册，注册号为NCT06443242。