Evaluation of the Efficacy of Thread Embedding Acupuncture Combined With Auricular Acupressure Based on Traditional Chinese Medicine Clinical Syndromes in Patients With Non-Organic Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Pittsburgh Sleep Quality Index (PSQI) Global Score From Baseline to End of Treatment
研究概览
简要总结
Chronic insomnia disorder is a common sleep disorder associated with impaired daytime functioning and may be accompanied by alterations in immune-inflammatory and gut-related biological processes. Traditional Chinese medicine (TCM) uses pattern differentiation to individualize treatment; however, the additional clinical value of pattern-based treatment compared with a standardized protocol remains insufficiently established.
This randomized controlled trial will evaluate whether individualized TCM pattern-based thread-embedding acupuncture combined with auricular acupressure improves sleep quality more effectively than the same therapeutic modalities delivered using a standardized fixed-point protocol in adults with chronic insomnia disorder.
Participants will be classified as having either Heart-Spleen Deficiency or Liver Qi Stagnation with Spleen Deficiency according to prespecified TCM diagnostic criteria and randomized 1:1 to individualized pattern-based treatment or standardized treatment.
The primary outcome is the change in Pittsburgh Sleep Quality Index (PSQI) score from baseline to the end of treatment. Secondary clinical outcomes include insomnia severity measured by the Insomnia Severity Index (ISI), gastrointestinal symptoms measured by the Gastrointestinal Symptom Rating Scale (GSRS), and adverse events.
Serum interleukin-6 (IL-6) and fecal calprotectin will be assessed as exploratory systemic and gut-related inflammatory biomarkers. These biomarkers are intended to explore biological correlates potentially relevant to gut-brain interactions and are not considered diagnostic markers of insomnia or direct measures of the microbiota-gut-brain axis.
Clinical outcomes will additionally be assessed at Week 10, four weeks after completion of scheduled treatment, to evaluate persistence of clinical effects.
详细描述
This is a randomized, participant- and outcome-assessor-blinded, active-controlled, parallel-group clinical trial enrolling 70 adults aged 40 to 75 years with Chronic Insomnia Disorder diagnosed according to the International Classification of Sleep Disorders, Third Edition (ICSD-3).
Eligible participants must also meet prespecified diagnostic criteria for one of two Traditional Chinese Medicine patterns:
- Heart-Spleen Deficiency, or
- Liver Qi Stagnation with Spleen Deficiency. Participants will be randomly allocated in a 1:1 ratio to an individualized TCM pattern-based treatment group or a standardized treatment group.
Individualized treatment group Participants will receive thread-embedding acupuncture and auricular acupressure using acupoints selected according to their prespecified TCM pattern diagnosis.
Standardized treatment group Participants will receive the same treatment modalities using a fixed set of acupoints applied irrespective of TCM pattern.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors will remain blinded to randomized treatment allocation. Treating practitioners cannot be blinded because they must administer either the individualized pattern-based or standardized acupoint protocol. Group allocation codes will be concealed from data analysts during the primary blinded analysis whenever feasible. Participants will not be informed of the acupoint-selection strategy assigned to their treatment group.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 to 75 years. Diagnosis of Chronic Insomnia Disorder according to ICSD-3 criteria. Pittsburgh Sleep Quality Index (PSQI) score ≥
- •Insomnia Severity Index (ISI) total score ≥
- •Mini-Mental State Examination (MMSE) score >
- •Diagnosis of one of the following prespecified Traditional Chinese Medicine patterns: Heart-Spleen Deficiency; or Liver Qi Stagnation with Spleen Deficiency.
- •TCM pattern diagnosis established according to prespecified standardized diagnostic criteria by a trained TCM practitioner.
- •Participants with hypertension or diabetes may be included if the condition is clinically stable, with no relevant change in medication regimen during the previous 3 months.
- •Able and willing to provide blood and stool samples according to study procedures.
- •Able to understand the study procedures and voluntarily provide written informed consent.
排除标准
- •Insomnia primarily attributable to another medical, neurological, psychiatric, or sleep disorder requiring alternative management.
- •Current acute or chronic gastrointestinal inflammatory disease, including inflammatory bowel disease, or acute diarrhea.
- •Known Crohn's disease or ulcerative colitis. Use of systemic corticosteroids, antibiotics, probiotics, or prebiotics within 4 weeks before baseline biomarker sampling.
- •Use of proton pump inhibitors within 2 weeks before baseline stool sampling. Regular use of non-steroidal anti-inflammatory drugs. Enema or colonoscopy within 1 month before stool sampling. Active autoimmune or systemic inflammatory disease, including rheumatoid arthritis.
- •Vaccination within 2 weeks before blood sampling. Acute infection or febrile illness at the time of biomarker assessment. Advanced renal, hepatic, or cardiovascular disease, including estimated glomerular filtration rate <45 mL/min/1.73 m², advanced hepatic failure, or New York Heart Association class III-IV heart failure.
- •Severe nocturia, defined as ≥3 episodes per night. Known obstructive sleep apnea or a high clinical likelihood of obstructive sleep apnea requiring further diagnostic evaluation.
- •Pregnancy or breastfeeding. Any clinical condition considered by the investigators to interfere substantially with sleep assessment, inflammatory biomarker interpretation, treatment safety, or protocol adherence.
研究组 & 干预措施
Standardized Fixed-Point Protocol
Participants will receive the same therapeutic modalities-thread-embedding acupuncture and auricular acupressure-using a fixed set of acupoints irrespective of TCM pattern diagnosis.
Thread-embedding acupuncture will be administered at baseline and Week 4. Auricular acupressure using Vaccaria seeds will be initiated at baseline and renewed every 2 weeks during the 6-week treatment period. Participants will receive the same self-massage instructions as participants in the individualized treatment group.
干预措施: Thread embedding acupuncture (Other)
Standardized Fixed-Point Protocol
Participants will receive the same therapeutic modalities-thread-embedding acupuncture and auricular acupressure-using a fixed set of acupoints irrespective of TCM pattern diagnosis.
Thread-embedding acupuncture will be administered at baseline and Week 4. Auricular acupressure using Vaccaria seeds will be initiated at baseline and renewed every 2 weeks during the 6-week treatment period. Participants will receive the same self-massage instructions as participants in the individualized treatment group.
干预措施: Auricular acupressure (Other)
Individualized TCM Pattern-Based Protocol
Participants will receive thread-embedding acupuncture combined with auricular acupressure. Acupoints will be selected according to the participant's prespecified TCM pattern:
- Heart-Spleen Deficiency; or
- Liver Qi Stagnation with Spleen Deficiency. Thread-embedding acupuncture will be administered at baseline and Week 4. Auricular acupressure using Vaccaria seeds will be initiated at baseline and renewed every 2 weeks during the 6-week treatment period. Participants will be instructed to self-massage each designated auricular point for 1-2 minutes, 3-5 times daily, particularly approximately 30 minutes before bedtime.
干预措施: Thread embedding acupuncture (Other)
Individualized TCM Pattern-Based Protocol
Participants will receive thread-embedding acupuncture combined with auricular acupressure. Acupoints will be selected according to the participant's prespecified TCM pattern:
- Heart-Spleen Deficiency; or
- Liver Qi Stagnation with Spleen Deficiency. Thread-embedding acupuncture will be administered at baseline and Week 4. Auricular acupressure using Vaccaria seeds will be initiated at baseline and renewed every 2 weeks during the 6-week treatment period. Participants will be instructed to self-massage each designated auricular point for 1-2 minutes, 3-5 times daily, particularly approximately 30 minutes before bedtime.
干预措施: Auricular acupressure (Other)
结局指标
主要结局
Change in Pittsburgh Sleep Quality Index (PSQI) Global Score From Baseline to End of Treatment
时间窗: Baseline to Week 6 (End of Treatment)
The Pittsburgh Sleep Quality Index consists of 19 self-rated items grouped into seven components. Each component is scored from 0 to 3, producing a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality. The primary treatment effect will be evaluated as the between-group difference in change in PSQI global score from baseline to the prespecified end-of-treatment assessment.
The change in PSQI scores
时间窗: From Baseline to Week 4, and Week 8 (2-week Post-treatment Follow-up)
This is a quantitative variable measured in scores. The Pittsburgh Sleep Quality Index (PSQI) consists of 19 self-rated items grouped into seven components. Each component is scored from 0 to 3, resulting in a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality.
次要结局
- Change in Insomnia Severity Index (ISI) Score(Baseline to Week 6 (End of Treatment))
- Change in Fecal Calprotectin(From baseline to week 6 (End of Treatment))
- Change in Serum Interleukin-6 (IL-6)(From baseline to week 6 (End of Treatment))
- Change in PSQI Global Score During Treatment and Follow-up(Baseline, Week 4, Week 6, and Week 10 (4-week post-intervention follow-up))
- Change in ISI Score During Treatment and Follow-up(Baseline, Week 4, Week 6, and Week 10 (4-week post-intervention follow-up))
- Change in Gastrointestinal Symptom Rating Scale (GSRS) Score(Baseline, Week 6, and Week 10 (4-week post-intervention follow-up))
- Incidence of Treatment-Emergent Adverse Events(From first intervention through Week 10)
- The change in serum IL-6 levels(From baseline to week 6 (End of Treatment))
- The change in fecal Calprotectin levels(From baseline to week 6 (End of Treatment))
- The change in ISI scores(From Baseline to Week 2, Week 4, Week 6 (End of Treatment), and Week 8 (2-week Post-treatment Follow-up))
- The change in GSRS score(From Baseline to Week 2, Week 4, Week 6 (End of Treatment), and Week 8 (2-week Post-treatment Follow-up))
- Adverse effects(At Week 2, Week 4, Week 6 (End of Treatment), and Week 8 (2-week Post-treatment Follow-up))
研究者
Le Thi Lan Huong
Principal Investigator
University of Medicine and Pharmacy at Ho Chi Minh City