[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-insomnia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-insomnia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,66,88,113],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100592649","comparative-efficacy-of-magnesium-supplement-and-melatonin-congener-in-young-adults-with-primary-insomnia-100592649",false,"NCT06996171","Comparative Efficacy of Magnesium Supplement and Melatonin Congener in Young Adults With Primary Insomnia","Inclusion Criteria:\n\n* Age 18-40 years\n* Gender: Male and Females (Non-pregnant \\& Non lactating)\n* Diagnosed cases of primary insomnia according to following criteria:\n\n  * Difficulty falling asleep, staying asleep or nonrestorative sleep\n  * This difficulty is present despite adequate opportunity \\& circumstance to sleep\n  * This impairment in sleep is associated with daytime impairment or distress\n  * This sleep difficulty occurs at least 3 times per week and has been a problem for at least 1 month\n\nExclusion Criteria:\n\n* Insomnia due to a known underlying cause\n* Any psychiatric illness\n* Active use of sedative hypnotics","ALL","18 Years","40 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"NA","Sleep is essential for our overall health and well-being, much like food and water. It plays a vital role in numerous bodily functions. Many studies have been conducted to determine the efficacy of melatonin congeners and Mg supplements in patients with insomnia separately. This study aims to compare the efficacy of melatonin and magnesium supplements in young adults with primary insomnia. Most insomnia studies focus on older adults or individuals with comorbidities. Targeting otherwise healthy young adults brings age-specific relevance and novel insight.",[26],"Primary Insomnia",[26,28,29],"Magnesium supplement","Melatonin congener","RECRUITING","2025-05-21",{"date":33,"type":34},"2025-05-30","ACTUAL",{"date":36,"type":34},"2025-05-05",{"date":38,"type":20},"2025-10-30",{"name":40,"class":41},"CMH Kharian Medical College","OTHER_GOV",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":15,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":42},"100581435","brisk-walking-training-compared-with-cognitive-behavioral-therapy-for-the-treatment-of-chronic-primary-insomnia-in-people-aged-60-years-or-above-a-randomized-partially-blinded-non-inferiority-trial-100581435","NCT06850272","Brisk Walking Training Compared with Cognitive Behavioral Therapy for the Treatment of Chronic Primary Insomnia in People Aged 60 Years or Above: a Randomized, Partially Blinded, Non-inferiority Trial","Inclusion Criteria:\n\n1. Aged ≥60 years;\n2. Ethnic Chinese; able to read, write and speak Cantonese\n3. Having a Hong Kong ID;\n4. Willing to wear an accelerometer on the wrist for a week to assess sleep parameters at T0, T1, and T2.\n5. Score ≥10 in the Insomnia Severity Index (ISI) (presence of insomnia)\n6. Experiencing any one of the following symptoms for ≥3 days per week\n\n   1. Difficulty initiating sleep; OR\n   2. Difficulty maintaining sleep; OR\n   3. Early-morning awakening with inability to return to sleep\n\nExclusion Criteria:\n\n1. Score ≥1 in the Chinese version of the Physical Activity Readiness Questionnaire (PAR-Q);\n2. Currently regularly practicing a moderate-intensity PA program such as brisk walking or Tai Chi (≥3 times a week, ≥30 minutes\u002Fsession);\n3. Currently receiving or scheduled to receive CBT-I during the study period;\n4. Score ≤16 in the validated telephone version of the Cantonese Mini-Mental State Examination (T-CMMSE).\n5. Working nightshifts and unable\u002Funwilling to discontinue such work pattern;\n6. Having a diagnosis of a major depressive disorder, anxiety disorders or other severe mental disorder (bipolar disorders, psychosis). Those with mild depression or anxiety disorders will not be excluded;\n7. Use of antidepressant or antipsychotic medication or under treatment of other serious diseases (e.g., cancer chemotherapy) known to affect sleep;\n8. Presence of any serious chronic diseases which affect sleep (e.g., cancer, autoimmune diseases).\n9. Having a serious somatic condition preventing the participation of brisk walking training\u002FCBT-I.","60 Years",{"count":51,"type":20},92,[23],"This study is a single-blinded (outcome assessor) and parallel-group non-inferiority RCT. Chinese older adults aged ≥60 years with chronic primary insomnia will be randomized evenly (1:1) to either the brisk walking training group or the CBT-I group. Participants in the brisk walking training group receive an eight-week instructor-led interval brisk walking training (40 minutes\u002Fsession, three sessions\u002Fweek). Participants in the CBT-I group receive standard-of-care group-based eight-session CBT-I (one session\u002Fweek). Self-reported and objective sleep outcomes are measured at baseline (T0), after completion of the intervention (T1), and six (T2), and 12 months after T1 (T3).",[26],"NOT_YET_RECRUITING","2025-02-23",{"date":58,"type":34},"2025-02-27",{"date":60,"type":20},"2025-03-10",{"date":62,"type":20},"2026-09-30",{"name":64,"class":65},"Chinese University of Hong Kong","OTHER",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":4},"100552614","enhancing-sleep-onset-the-power-of-tactile-breath-pacer-in-cognitive-behavioral-therapy-for-insomnia-100552614","NCT06475378","Enhancing Sleep Onset: the Power of Tactile Breath Pacer in Cognitive Behavioral Therapy for Insomnia","MOONBIRD","Inclusion Criteria:\n\n* Patients must be diagnosed with chronic insomnia.\n\nExclusion Criteria:\n\n* Underaged patients and patients with untreated comorbid (sleep) disorders will be excluded from the study.",true,{"count":75,"type":20},72,[23],"The purpose of the study is to evaluate the effectiveness of technology-assisted breathing exercises combined with Cognitive Behavioral Therapy for Insomnia (CBT-I) in primary insomnia patients to investigate. For this purpose, we will conduct 1 study. This will be a randomized controlled trial in which 72 patients randomly and stratified by gender will be divided into 3 groups. A first group follows the standard treatment Cognitive Behavioral Therapy for Insomnia (CBT-I), the second group follows the combined treatment Cognitive Behavioral Therapy for Insomnia with a technology supported breathing exercises with a tactile breath pacer device (Moonbird) (CBT-I + Moonbird) and a third group follows the standard treatment Cognitive Behavioral Therapy for Insomnia and receives a non-functional technology supported breathing exercises with a tactile breath pacer device (Moonbird). The therapy, baseline measurements, screening for inclusion and questionnaire administration and ambulatory polysomnography (PSG) will be performed by the sleep psychologists at the UZ Brussel. The polysomnography screening for in- or exclusion (i.e. presence of other untreated sleep disorders) will be performed at the UZ Brussel. Furthermore, two follow-up measurements will be scheduled. The first measurement will take place immediately after the treatment while the second measurement will take place 3 months after the treatment.",[26],"2025-02-13",{"date":81,"type":34},"2025-02-18",{"date":83,"type":20},"2025-03-01",{"date":85,"type":20},"2026-09-01",{"name":87,"class":65},"Vrije Universiteit Brussel",{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":95,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":42},"100576247","acupoint-selection-based-on-meridian-theory-in-primary-insomnia-of-liver-depression-and-spleen-deficiency-type-100576247","NCT06782815","Acupoint Selection Based on Meridian Theory in Primary Insomnia of Liver Depression and Spleen Deficiency Type","Study on the Curative Effect and Autonomic Nerve Function of Primary Insomnia Patients with Liver Depression and Spleen Deficiency Type Based on Acupoint Selection of Meridian Theory","Inclusion Criteria:\n\n* In line with the diagnostic criteria of insomnia of liver depression and spleen deficiency type in traditional Chinese medicine :\n* In line with the Western diagnostic criteria for insomnia ;\n* 18 ≤ age ≤ 40 years old, male or female ;\n* patients with a course of more than two weeks ; Note: The above criteria must be met for inclusion in this study.\n\nExclusion Criteria:\n\n* Insomnia caused by a variety of organic diseases, neurological or psychiatric disorders\n* Pregnancy, lactation or drug allergy\n* There are more serious primary diseases such as cardiovascular and cerebrovascular diseases, gastrointestinal diseases, endocrine system diseases, or psychiatric patients.\n* Patients with coagulation dysfunction and bleeding tendency.",{"count":96,"type":20},96,[23],"The classical literature combined with modern medicine to select acupoints, in order to intervene in the autonomic nerve function of the superior cervical sympathetic ganglion as an opportunity, put forward the meridian acupoints mainly to reconcile the head orifices Ying Wei, acupuncture treatment of primary insomnia clinical research. Heart rate variability ( HRV ), Pittsburgh sleep quality index ( PSQI ), polysomnography ( PSG ) and the MOS item short from health survey ( SF-36 ) were observed. Insomnia Severity Index ( ISI ), Dysfunctional Beliefs and Attitudes about Sleep Scale 16 ( DBAS-16 ), GABA, Glx and other secondary indicators were used to clarify the clinical short-term and long-term efficacy of different acupoints in the treatment of patients with primary insomnia and the intervention effect on HRV.",[26],[101,102,103],"Liver stagnation and spleen deficiency type insomnia","Acupuncture","Randomized controlled trial","2025-02-10",{"date":106,"type":34},"2025-02-11",{"date":108,"type":34},"2024-01-01",{"date":110,"type":20},"2026-12-31",{"name":112,"class":65},"Chuanlong Zhou",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":73,"sex":15,"minAge":16,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":124,"conditions":125,"keywords":126,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":42},"100503101","the-study-on-the-evaluation-of-acupuncture-therapy-on-primary-insomnia-100503101","NCT05830877","The Study on the Evaluation of Acupuncture Therapy on Primary Insomnia","The RCT Study on the Evaluation of Clinical Effect of Primary Insomnia Treated With the Tiaoshen Acupuncture","Inclusion Criteria:\n\n* Conforming to the diagnostic criteria of traditional Chinese and Western medicine for chronic insomnia;\n* Age range: 18-70 years old;\n* PSQI score\\>7 points; SAS score \\> 50 or SDS score \\> 53;\n* No communication and cognitive impairment;\n* No use or withdrawal of psychoactive drugs such as anti-anxiety within one month; ·No major physical diseases;\n* Those who voluntarily accept the research content and can complete various scale evaluations, polysomnography monitoring and HRV;\n* Sign an informed consent form prior to the start of the study.\n\nExclusion Criteria:\n\n* Those who do not meet the inclusion criteria;\n* Persons with a history of severe mental illness, severe head injury, and significant disturbance of consciousness;\n* Those with severe liver and renal insufficiency and bleeding tendencies;\n* Alcoholism (liquor ≥ 100ml\u002Fday), smoking (≥ 15 cigarettes\u002Fday), drug abuse or taking psychotropic drugs;\n* People with other sleep disorders, such as sleep apnea hypopnea syndrome, paroxysmal sleeping sickness, and REM sleep behavioral disorders;\n* Pregnant or nursing;\n* Those with other major diseases and poor control;\n* Other persons who are unwilling to sign informed consent.","70 Years",{"count":122,"type":20},84,[23],"Through the recruition of outpatients who clinically meet the diagnostic criteria and inclusion criteria of PI, the acupuncture group adopts Tiaoshen acupuncture, and the placebo acupuncture group adopts non-insertive acupuncture supported by the Park device, and the Pittsburgh Sleep Quality Index (PSQI) is used as the main index to evaluate the patients through the scale; subjective indicators like Chalder 14-item fatigue scale, Epworth sleepiness rating, self-rating anxiety scale (SAS), self-rating depression scale (SDS) and objective indicators like polysomnography (PSG), heart rate variability (HRV) is regarded as a secondary index, and then evaluate the clinical efficacy of Tiaoshen acupuncture on PI and explore its mechanism.",[26],[127,26,128],"acupuncture","RCT","2024-06-13",{"date":131,"type":34},"2024-06-14",{"date":133,"type":34},"2023-05-10",{"date":135,"type":20},"2025-12-31",{"name":137,"class":65},"The Third Affiliated hospital of Zhejiang Chinese Medical University"]