Individualized TCM Pattern-Based Thread-Embedding Acupuncture Plus Auricular Acupressure for Chronic Insomnia
Evaluación de la eficacia de la acupuntura con inserción de hilos combinada con acupresión auricular basada en síndromes clínicos de la Medicina Tradicional China en pacientes con insomnio no orgánico
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Thread-embedding acupuncture will be performed twice, 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 the auricular points for 1-2 minutes per point, 3-5 times daily, particularly approximately 30 minutes before bedtime.
The active treatment period will last 6 weeks, followed by a 4-week post-treatment follow-up, with the final assessment at Week 10. The Week 10 assessment is intended to evaluate the persistence of clinical effects after treatment discontinuation.
Sleep outcomes will be assessed using the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI). Gastrointestinal symptoms will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS). Adverse events will be monitored throughout the study.
Serum IL-6 and fecal calprotectin will be measured at baseline and Week 6. These biomarkers are considered exploratory mechanistic outcomes representing systemic and gut-related inflammatory activity. Because the study does not directly assess gut microbiota composition, microbial metabolites, intestinal permeability, or central nervous system biomarkers, IL-6 and fecal calprotectin will not be interpreted as direct measures or proof of a microbiota-gut-brain axis mechanism.
Biomarker sampling procedures Baseline biomarker samples will be collected before the first study intervention. If a participant has an acute febrile illness or clinically significant acute infection at a scheduled biomarker assessment, blood and stool sampling may be postponed within a prespecified allowable window according to the biomarker sampling standard operating procedure (SOP). For baseline assessments, the first study intervention will not be initiated until pretreatment biomarker samples have been collected. For the Week 6 assessment, biomarker sampling may be rescheduled within the prespecified allowable window without requiring withdrawal from the clinical study. The participant will remain in the study unless the acute illness otherwise meets a protocol-defined criterion for treatment discontinuation or study withdrawal.
Prespecified analytic components
The study includes two distinct prespecified analytic components:
-
Randomized treatment-effect analysis The primary analysis will compare the clinical efficacy of individualized TCM pattern-based treatment with the standardized treatment protocol according to randomized treatment assignment. The primary clinical endpoint will be the between-group difference in change in PSQI score from baseline to Week 6.
Changes in ISI, GSRS, IL-6, fecal calprotectin, and adverse events will be evaluated as secondary or exploratory outcomes.
-
Exploratory baseline phenotyping analysis
A separate exploratory analysis using pretreatment data only will examine whether Heart-Spleen Deficiency and Liver Qi Stagnation with Spleen Deficiency represent clinically and biologically distinguishable phenotypes. This analysis will examine:
- differences in insomnia severity between the two TCM patterns;
- differences in baseline serum IL-6;
- differences in baseline fecal calprotectin;
- associations of IL-6 with insomnia severity;
- associations of fecal calprotectin with insomnia severity; and
- whether these biomarker-insomnia associations differ according to TCM pattern. The baseline phenotyping analysis will not evaluate randomized treatment efficacy or post-treatment treatment effects.
All mechanistic and baseline phenotyping analyses will be considered exploratory and hypothesis-generating.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Huong TL Le, MD, MSc
- Número de teléfono: +84-983506700
- Correo electrónico: lanhuong@ump.edu.vn
Ubicaciones de estudio
-
-
City
-
Ho Chi Minh City, City, Vietnam, 700000
- Reclutamiento
- Thong Nhat Hospital
-
Contacto:
- Head of Department
- Número de teléfono: +84-28 3869 0277
- Correo electrónico: thongnhathospital@bvtn.org.vn
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Age 40 to 75 years. Diagnosis of Chronic Insomnia Disorder according to ICSD-3 criteria. Pittsburgh Sleep Quality Index (PSQI) score ≥5. Insomnia Severity Index (ISI) total score ≥10. Mini-Mental State Examination (MMSE) score >24. 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.
Exclusion Criteria 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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. |
Thread embedding acupuncture is performed twice at a 4-week interval using the points HT7 (Shenmen), PC6 (Neiguan), SP6 (Sanyinjiao), GB20 (Fengchi), and Anmian. Auricular acupressure using Vaccaria seeds is applied and replaced every 2 weeks on the points Shenmen (TF4), Subcortex, Occiput, Forehead, Kidney, and Endocrine. Participants are instructed to perform self-massage on the ear seeds 3-5 times daily for 1-2 minutes per point, particularly 30 minutes before bedtime. Thread embedding acupuncture is performed twice at a 4-week interval using absorbable sutures. The selection of acupoints is strictly tailored to the participant's Traditional Chinese Medicine (TCM) syndrome differentiation: Heart-Spleen Deficiency: The procedure utilizes the points BL15 (Xinshu), BL20 (Pishu), ST36 (Zusanli), SP6 (Sanyinjiao), and ST25 (Tianshu). Liver Qi Stagnation with Spleen Deficiency: The procedure utilizes the points BL18 (Ganshu), LR3 (Taichong), GB34 (Yanglingquan), SP6 (Sanyinjiao), and PC6 (Neiguan). Auricular acupressure using Vaccaria seeds (ear seeds) is applied to reflex points on the ear and replaced every 2 weeks throughout the 8-week study period. The selection of ear points is customized based on the TCM syndrome. Heart-Spleen Deficiency: The points include Heart (CO15), Spleen (CO13), Stomach (CO4), TF4 (Shenmen), and Subcortex (AT4). Liver Qi Stagnation: The points include Liver (CO12), Gallbladder (CO11), Sympathetic (AH6a), TF4 (Shenmen), and Subcortex (AT4). Participants are instructed to perform self-massage on the ear seeds for 1-2 minutes per point, 3-5 times daily, particularly 30 minutes before bedtime. |
|
Experimental: 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:
|
Thread embedding acupuncture is performed twice at a 4-week interval using the points HT7 (Shenmen), PC6 (Neiguan), SP6 (Sanyinjiao), GB20 (Fengchi), and Anmian. Auricular acupressure using Vaccaria seeds is applied and replaced every 2 weeks on the points Shenmen (TF4), Subcortex, Occiput, Forehead, Kidney, and Endocrine. Participants are instructed to perform self-massage on the ear seeds 3-5 times daily for 1-2 minutes per point, particularly 30 minutes before bedtime. Thread embedding acupuncture is performed twice at a 4-week interval using absorbable sutures. The selection of acupoints is strictly tailored to the participant's Traditional Chinese Medicine (TCM) syndrome differentiation: Heart-Spleen Deficiency: The procedure utilizes the points BL15 (Xinshu), BL20 (Pishu), ST36 (Zusanli), SP6 (Sanyinjiao), and ST25 (Tianshu). Liver Qi Stagnation with Spleen Deficiency: The procedure utilizes the points BL18 (Ganshu), LR3 (Taichong), GB34 (Yanglingquan), SP6 (Sanyinjiao), and PC6 (Neiguan). Auricular acupressure using Vaccaria seeds (ear seeds) is applied to reflex points on the ear and replaced every 2 weeks throughout the 8-week study period. The selection of ear points is customized based on the TCM syndrome. Heart-Spleen Deficiency: The points include Heart (CO15), Spleen (CO13), Stomach (CO4), TF4 (Shenmen), and Subcortex (AT4). Liver Qi Stagnation: The points include Liver (CO12), Gallbladder (CO11), Sympathetic (AH6a), TF4 (Shenmen), and Subcortex (AT4). Participants are instructed to perform self-massage on the ear seeds for 1-2 minutes per point, 3-5 times daily, particularly 30 minutes before bedtime. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Pittsburgh Sleep Quality Index (PSQI) Global Score From Baseline to End of Treatment
Periodo de tiempo: 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. |
Baseline to Week 6 (End of Treatment)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Insomnia Severity Index (ISI) Score
Periodo de tiempo: Baseline to Week 6 (End of Treatment)
|
The Insomnia Severity Index is a 7-item questionnaire assessing the severity and impact of insomnia symptoms. Total scores range from 0 to 28, with higher scores indicating greater insomnia severity. |
Baseline to Week 6 (End of Treatment)
|
|
Change in Fecal Calprotectin
Periodo de tiempo: From baseline to week 6 (End of Treatment)
|
Fecal calprotectin will be measured as an exploratory biomarker of gut-related inflammatory activity. Changes will be compared between randomized treatment groups. Fecal calprotectin will not be interpreted as a direct measure of gut microbiota composition or as proof of a microbiota-gut-brain axis mechanism. |
From baseline to week 6 (End of Treatment)
|
|
Change in Serum Interleukin-6 (IL-6)
Periodo de tiempo: From baseline to week 6 (End of Treatment)
|
Serum IL-6 will be measured as an exploratory biomarker of systemic inflammatory activity. Changes will be compared between randomized treatment groups. IL-6 is not considered a diagnostic biomarker of insomnia in this study. |
From baseline to week 6 (End of Treatment)
|
|
Change in PSQI Global Score During Treatment and Follow-up
Periodo de tiempo: Baseline, Week 4, Week 6, and Week 10 (4-week post-intervention follow-up)
|
PSQI global scores will also be assessed at intermediate and post-treatment follow-up visits to characterize the trajectory and persistence of treatment effects. |
Baseline, Week 4, Week 6, and Week 10 (4-week post-intervention follow-up)
|
|
Change in ISI Score During Treatment and Follow-up
Periodo de tiempo: Baseline, Week 4, Week 6, and Week 10 (4-week post-intervention follow-up)
|
ISI scores will be assessed repeatedly to characterize changes in insomnia severity during treatment and after treatment discontinuation. |
Baseline, Week 4, Week 6, and Week 10 (4-week post-intervention follow-up)
|
|
Change in Gastrointestinal Symptom Rating Scale (GSRS) Score
Periodo de tiempo: Baseline, Week 6, and Week 10 (4-week post-intervention follow-up)
|
The GSRS will be used to assess gastrointestinal symptom burden during the study. Higher scores indicate greater gastrointestinal symptom severity. |
Baseline, Week 6, and Week 10 (4-week post-intervention follow-up)
|
|
Incidence of Treatment-Emergent Adverse Events
Periodo de tiempo: From first intervention through Week 10
|
Treatment-related and treatment-emergent adverse events, including local pain, bleeding, bruising, dizziness, fainting, infection, skin irritation, or other unexpected events, will be systematically recorded. Event severity, relationship to treatment, management, and outcome will be documented. |
From first intervention through Week 10
|
Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016 Jul 19;165(2). doi: 10.7326/P16-9016. Epub 2016 May 3. No abstract available.
- Huo ZJ, Guo J, Li D. Effects of acupuncture with meridian acupoints and three Anmian acupoints on insomnia and related depression and anxiety state. Chin J Integr Med. 2013 Mar;19(3):187-91. doi: 10.1007/s11655-012-1240-6. Epub 2012 Aug 18.
- Zhuang J, Wu J, Fan L, Liang C. Observation on the Clinical Efficacy of Traditional Chinese Medicine Non-Drug Therapy in the Treatment of Insomnia: A Systematic Review and Meta-Analysis Based on Computer Artificial Intelligence System. Comput Intell Neurosci. 2022 Oct 11;2022:1081713. doi: 10.1155/2022/1081713. eCollection 2022.
- Guo J, Wang LP, Liu CZ, Zhang J, Wang GL, Yi JH, Cheng JL. Efficacy of acupuncture for primary insomnia: a randomized controlled clinical trial. Evid Based Complement Alternat Med. 2013;2013:163850. doi: 10.1155/2013/163850. Epub 2013 Sep 18.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- Inflamación
- Interleucina 6
- acupresión auricular
- Calprotectina fecal
- Síndrome de MTC
- Trastorno de insomnio crónico
- insomnio no orgánico
- Thread-embedding acupuncture
- Insomnia severity
- Traditional Chinese medicine pattern differentiation
- Heart-Spleen Deficiency
- Liver Qi Stagnation with Spleen Deficiency
- Gut-brain interaction
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 653/ĐHYD-HĐĐĐ
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .