[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"insomnia-nonorganic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:insomnia-nonorganic":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100635440","thread-embedding-plus-auricular-acupressure-for-non-organic-insomnia-based-on-traditional-medicine-pattern-differentiation-100635440",false,"NCT07552714","Thread Embedding Plus Auricular Acupressure for Non-Organic Insomnia Based on Traditional Medicine Pattern Differentiation","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","Inclusion Criteria:\n\n* Age: 40 to 75 years.\n* Cognitive Function: Mini-Mental State Examination (MMSE) score \\> 24.\n* Stable Comorbidities: Participants with hypertension or diabetes must be well-controlled with medication (Blood Pressure \\\u003C 140\u002F90 mmHg, HbA1c \\\u003C 7%) and have no changes in their medication regimen within the last 3 months.\n* Modern Medical Criteria: Diagnosis of Chronic Insomnia Disorder according to the International Classification of Sleep Disorders, 3rd Edition (ICSD-3).\n* Sleep Quality Scores: A Pittsburgh Sleep Quality Index (PSQI) score \\>= 5 and a total Insomnia Severity Index (ISI) score \\>= 10.\n* TCM Syndrome: Diagnosed with one of the following Traditional Chinese Medicine syndromes: Heart-Spleen Deficiency, Liver Qi Stagnation, or Liver Qi Stagnation with Spleen Deficiency.\n* Informed Consent: Participants must voluntarily sign the informed consent form and agree to comply with study requirements, including stool sample collection.\n\nExclusion Criteria:\n\n* Secondary Insomnia: Sleep disturbances caused by organic conditions (e.g., brain tumor, acute pain, hyperthyroidism, or severe cardiovascular disease).\n* Gastrointestinal Disorders: Current acute or chronic gastrointestinal diseases (e.g., ulcerative colitis, Crohn's disease, or acute diarrhea).\n* Specific Medications and Supplements: \\* Use of antibiotics, corticosteroids, or Probiotic\u002FPrebiotic supplements within 4 weeks prior to the study.\n* Use of Proton Pump Inhibitors (PPIs) such as Omeprazole or Esomeprazole within the last 2 weeks.\n* Regular use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as Ibuprofen, Meloxicam, or Diclofenac.\n* Medical Procedures: Enema or colonoscopy performed within 1 month prior to the study.\n* Immune Conditions: Autoimmune diseases or rheumatoid arthritis.\n* Vaccination: Vaccination (e.g., influenza vaccine) within 2 weeks prior to blood collection.\n* Advanced Chronic Diseases: Late-stage chronic conditions including renal failure (eGFR \\\u003C 45), liver failure, or stage III-IV heart failure.\n* Severe Nocturia: Urinating \\>= 3 times per night.\n* Obstructive Sleep Apnea (OSA): Patients with obesity, loud snoring, and excessive daytime sleepiness.\n* Pregnancy and Lactation: Women who are pregnant or breastfeeding.","ALL","40 Years","75 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"NA","Non-organic insomnia is a prevalent disorder that significantly impairs quality of life, characterized by difficulty initiating or maintaining sleep alongside daytime functional decline. This condition is particularly common among adults facing chronic stress, which increases the risk of chronic diseases and dysregulates the Microbiota-Gut-Brain Axis (MGBA)-a bidirectional communication system between the central nervous system and the gut microbiota. Prolonged sleep deprivation and stress can trigger inflammatory responses and gut dysbiosis, which in turn exacerbate emotional and sleep disturbances. While conventional sedative-hypnotics often carry side effects and risks of dependency, traditional medicine interventions are emerging as potential sustainable solutions. This study evaluates the efficacy of thread embedding combined with auricular acupressure based on individualized traditional Chinese medicine syndrome differentiation, while clarifying the relationship between clinical sleep improvement and changes in MGBA-related inflammatory markers, specifically interleukin-6 and calprotectin.\n\nThe goal of this clinical trial is to evaluate the clinical efficacy and preliminarily investigate the mechanisms of action-via the Microbiota-Gut-Brain Axis-of individualized Traditional Chinese Medicine (targeting Heart-Spleen Deficiency and Liver Qi Stagnation syndromes) using thread embedding acupuncture combined with auricular acupressure to improve sleep quality in patients with insomnia, compared to a non-individualized protocol. The main questions it aims to answer are:\n\n* Does the combined method of thread embedding acupuncture and auricular acupressure based on syndrome differentiation improve sleep quality more effectively than the standardized protocol?\n* Is there a significant difference in the change of IL-6 and Calprotectin levels following treatment in the intervention group compared to the control group?\n* Does post-treatment clinical improvement correlate with the reduction of these inflammatory markers?\n\nParticipants will:\n\n* Receive thread embedding acupuncture sessions every 4 weeks and have ear seeds (auricular acupressure) replaced every 2 weeks . Self-massage the ear seeds for 1 to 2 minutes several times each day, especially before bedtime.\n* Complete assessments of sleep quality (PSQI, ISI) and digestive health (GSRS) every 2 weeks through week 8.\n* Provide blood and stool samples at the start and end of the study to measure inflammation markers.\n* Be monitored for any adverse effects, such as local pain, dizziness, or needle fainting, during the trial period.",[27],"Insomnia, Nonorganic",[29,30,31,32,33,34,35],"non-organic insomnia","thread embedding acupuncture","auricular acupressure","TCM Syndrome","Interleukin 6","Calprotectin","Gut-brain axis","NOT_YET_RECRUITING","2026-05-05",{"date":39,"type":40},"2026-05-08","ACTUAL",{"date":42,"type":21},"2026-05-01",{"date":44,"type":21},"2027-12",{"name":46,"class":47},"University of Medicine and Pharmacy at Ho Chi Minh City","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":5},"100634776","acupuncture-with-five-shu-points-for-insomnia-in-heart-spleen-deficiency-100634776","NCT07544082","Acupuncture With Five Shu Points for Insomnia in Heart-Spleen Deficiency","Efficacy of Five Shu Point Acupuncture in the Treatment of Insomnia in Patients With Heart-Spleen Deficiency Pattern: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients aged 18 years or older who voluntarily consent to participate in the study.\n* Patients who have never used or have discontinued insomnia medication within 2 weeks prior to study enrollment.\n* Patients meeting the diagnostic criteria for insomnia according to the DSM-V of the American Psychiatric Association, specifically as follows:\n\nA. The patient complains about sleep quantity or quality, including one or more of the following symptoms: difficulty initiating sleep; difficulty maintaining sleep, characterized by frequent awakenings or trouble returning to sleep after awakening; early morning awakening with inability to return to sleep.\n\nB. Sleep difficulty occurs for at least 3 months. C. Sleep disturbance causes significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning.\n\nD. Sleep difficulty occurs at least 3 nights per week. E. Sleep difficulty occurs despite adequate opportunity for sleep. F. Insomnia is not better explained by another sleep disorder (e.g., narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder).\n\nG. Co-existing mental disorders or medical conditions do not adequately explain the predominant complaint of insomnia.\n\nH. Insomnia is not attributable to the physiological effects of a substance.\n\n* Patients who are able to understand Vietnamese.\n* Patients meeting the diagnostic criteria for Heart-Spleen dual deficiency syndrome according to Jing Lv, requiring the presence of mandatory symptoms + 2 primary symptoms + 2 secondary symptoms + tongue and pulse findings, specifically:\n\nMandatory symptoms\n\n* Sleeplessness throughout the night, or light sleep with frequent awakening; fragmented sleep.\n* Frequent nightmares.\n* Early morning awakening with inability to fall back asleep.\n\nPrimary symptoms\n\nPalpitations, forgetfulness. Mental fatigue, poor appetite. Pale, unhealthy complexion. Secondary symptoms\n\nDizziness, blurred vision. Weakness of limbs. Abdominal distension, loose stools. Tongue and pulse findings\n\nPale tongue with thin white coating. Thin, weak, forceless pulse.\n\nExclusion Criteria:\n\n* Patients diagnosed with other sleep disorders such as sleep apnea syndrome or narcolepsy.\n* Patients previously diagnosed with neurological or psychiatric disorders (e.g., anxiety disorder, autism spectrum disorder, depression, obsessive-compulsive disorder, rapid eye movement sleep behavior disorder) prior to study enrollment.\n* Patients currently using antidepressants or psychiatric medications.\n* Patients participating in other clinical trials involving behavioral, psychological, or complementary medical interventions during the study period.\n* The patient no longer agrees to continue participation.\n* Occurrence of uncomfortable symptoms during the study, such as needle syncope, nausea, headache, dizziness, sweating, etc.\n* Significant worsening of the condition or development of new complications.\n* Non-adherence to the treatment protocol, making continuation impossible.","18 Years",{"count":58,"type":21},46,[24],"This study was designed as a randomized controlled trial (RCT) with a multicenter, single-blind methodology. Participants diagnosed with insomnia attributable to the Heart-Spleen Deficiency pattern, receiving treatment at the Ho Chi Minh City Hospital of Traditional Medicine and Hospital 1A, were randomly allocated into two groups.",[27],[63,64,65,66],"Five-Shu acupoints","insomnia","acupuncture","Heart-Spleen deficiency","RECRUITING","2026-04-19",{"date":70,"type":40},"2026-04-22",{"date":72,"type":40},"2026-03-01",{"date":74,"type":21},"2026-09-10",{"name":46,"class":47},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":96,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100575042","comparative-efficacy-of-brt-and-cbt-i-for-insomnia-100575042","NCT06767137","Comparative Efficacy of BRT and CBT-I for Insomnia","Comparative Efficacy of Bedtime Restriction Therapy and Cognitive Behavioral Therapy for Insomnia - a Randomized Controlled Non-inferiority Trial","SLEEPwindow","Inclusion Criteria:\n\n* Must meet DSM-5 criteria for insomnia disorder.\n* Adults aged 18 to 80 years\n* Capable of giving written informed consent.\n* Sufficient fluency in the study site's language (i.e., German or French) to understand all study-related information.\n\nExclusion Criteria:\n\n* Unstable, progressive, or degenerative medical condition\n* Acute pain or poorly managed chronic pain\n* Suicidality\n* Uncontrolled psychiatric condition requiring treatment outside of study\n* Alcohol or drug abuse or dependency\n* Diagnosis of psychosis, bipolar disorder, autism, borderline personality disorder, or antisocial personality disorder\n* Clinical evidence of sleep disorders other than insomnia (e.g., sleep apnea, restless legs, periodic limb movements in sleep, parasomnia)\n* Evidence of intellectual disability\n* Regular intake of benzodiazepines (BZD) or benzodiazepine receptor agonists (BZDRA)\n* Alteration of medication within 4 weeks prior to study treatment or planned alteration during the trial period (stable medication except BZD or BZDRA does not lead to exclusion)\n* Current other psychotherapy for insomnia\n* Known pregnancy or breastfeeding\n* Inability to comply with study procedure\n* Insufficient fluency in German or French to complete the study","80 Years",{"count":86,"type":21},160,[24],"This study evaluates two behavioral treatments for patients with insomnia disorder: Bedtime Restriction Therapy (BRT) and Cognitive Behavioral Therapy for Insomnia (CBT-I). Both therapies aim to improve the clinical symptomatology of insomnia by teaching participants techniques to better manage their sleep schedule and habits. BRT is a simpler and shorter therapy focused on aligning the time spent in bed with reported sleep time. CBT-I includes additional components such as relaxation techniques and cognitive exercises. The study will compare these treatments to see if BRT is as effective as CBT-I in improving the clinical symptomatology of insomnia.",[90,91,92,93,94,27,95],"Insomnia Disorders","Insomnia Disorder","Insomnia","Insomnia Chronic","Insomnia, Primary","Insomnia Type; Sleep Disorder",[64,97,98,99],"cognitive behavioral therapy","bedtime restriction","sleep restriction","2025-02-13",{"date":102,"type":40},"2025-02-17",{"date":104,"type":21},"2025-03-10",{"date":106,"type":21},"2027-11-01",{"name":108,"class":47},"Christoph Nissen",2]