[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rapid-eye-movement-sleep-behavior-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rapid-eye-movement-sleep-behavior-disorder":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100570694","phase-4-multimodal-image-technologies-investigate-the-role-and-mechanism-of-probiotics-in-improving-rbd-with-parkinsons-disease-100570694",false,"NCT06710574","Multimodal Image Technologies Investigate the Role and Mechanism of Probiotics in Improving RBD with Parkinson's Disease","Multimodal Image Technologies Investigate the Role and Mechanism of Probiotics in Improving Rapid Eye Movement Behavior Disorder with Parkinson's Disease","Inclusion Criteria:\n\nInclusion criteria for PD-RBD patients:\n\n* Age between 40 and 80 years, both males and females\n* Patients with idiopathic Parkinson's disease, meeting the MDS clinical diagnostic criteria for Parkinson's disease (2015)\n* Modified Hoehn and Yahr stage of Parkinson's disease ≤ stage 3\n* No dementia, with a Mini-Mental State Examination (MMSE) score \\> 24\n* No depression or anxiety, as indicated by Hamilton Depression Scale score \\\u003C 9 and Anxiety Scale score \\\u003C 14\n* Rapid Eye Movement Sleep Behavior Disorder (RBD) screening questionnaire score \\> 5, diagnosed with RBD based on polysomnography results, and exclusion of obstructive sleep apnea\n* Stable condition of Parkinson's disease motor symptoms and RBD symptoms in the month prior to enrollment, with no adjustments to Parkinson's disease medications in the month prior to enrollment\n* Discontinuation of benzodiazepines such as clonazepam and melatonin in the month prior to enrollment\n* No use of probiotics, prebiotics (including lactulose), or antibiotics for the two months prior to enrollment, if used, a two-month washout period should be observed\n* Understanding and willingness to comply with the study protocol, agreeing to participate, and signing the informed consent form.\n\nInclusion criteria for iRBD patients:\n\n* Age between 40 and 80 years, both males and females\n* Rapid Eye Movement Sleep Behavior Disorder (RBD) screening questionnaire score \\> 5, diagnosed with RBD based on polysomnography results, and exclusion of obstructive sleep apnea or restless legs syndrome\n* No dementia, with a Mini-Mental State Examination (MMSE) score \\> 24\n* No depression or anxiety, as indicated by Hamilton Depression Scale score \\\u003C 9 and Anxiety Scale score \\\u003C 14\n* Discontinuation of benzodiazepines such as clonazepam and melatonin in the month prior to enrollment\n* No use of probiotics, prebiotics (including lactulose), or antibiotics for the two months prior to enrollment, if used, a two-month washout period should be observed\n* Understanding and willingness to comply with the study protocol, agreeing to participate, and signing the informed consent form.\n\nInclusion criteria for healthy subjects\n\n* Age between 40 and 80 years, age and gender matched with the above two groups of patients\n* Rapid Eye Movement Sleep Behavior Disorder screening questionnaire score ≤ 5, exclusion of RBD or obstructive sleep apnea based on polysomnography results\n* No dementia, with a Mini-Mental State Examination (MMSE) score \\> 24.\n* No depression or anxiety, as indicated by Hamilton Depression Scale score \\\u003C 9 and Anxiety Scale score \\\u003C 14\n* No severe constipation, not meeting the diagnostic criteria for Rome III chronic constipation; No use of probiotics, prebiotics (including lactulose), or antibiotics for the two months prior to enrollment, if used, a two-month washout period should be observed\n* Understanding and willingness to comply with the study protocol, agreeing to participate, and signing the informed consent form.\n\nExclusion Criteria:\n\nPD-RBD exclusion criteria:\n\n* Parkinsonism plus syndrome and secondary parkinsonism such as multiple system atrophy, progressive supranuclear palsy, cortical basal ganglia degeneration, dementia with Lewy bodies, vascular parkinsonism, post-encephalitis parkinsonism, or any other non-primary parkinsonism\n* Taking any probiotics or prebiotics (including lactulose) or antibiotics within 2 months before enrollment\n* Adjustment of Parkinson's disease medication within 1 month before enrollment; In group 1 month before taking clonazepam and benzodiazepines medicine melatonin, etc.\n* With the following diseases such as Alzheimer's disease, malignant tumor, spinal cord lesions, epilepsy, autonomic nerve disease (urinary retention, urinary incontinence or orthostatic hypotension, vertical drop in blood pressure in five minutes more than 30\u002F15 MMHG), etc.; New onset of cerebrovascular disease or severe sequelae of cerebrovascular disease within 3 months, affecting the assessment\n* Patients with anxiety or depression and taking medication\n* Serious cardiovascular diseases (such as the American heart association heart function class for Ⅲ - Ⅳ of congestive heart failure, the 6 month history of myocardial infarction, etc.)\n* Severe liver and kidney dysfunction, cereal third transaminase, aspertate aminotransferase, total bilirubin is higher than the upper limit of normal value of 1. 5 times; Serum creatinine is higher than the upper limit of normal value 1. 5 times\n* Pregnant and lactating women or pregnant women aged 40-60 years with positive HCG;\n* Known to be allergic to Bifidobacterium triple viable capsules, Bacillus licheniformis, or their excipients\n* Has a history of history of drug abuse or alcohol dependence\n* Were enrolled in another clinical trial at enrollment\n* Refusal to participate in the study or inability to cooperate with the study investigator; The researchers judgment for doesn't fit into the group of patients.\n\nExclusion criteria for iRBD:\n\n* PD motor symptoms and parkinsonism were included in the PD-RBD group; \"Parkinsonism plus syndrome and secondary parkinsonism, such as multiple system atrophy, progressive supranuclear palsy, cortical basal ganglia degeneration, dementia with Lewy bodies, vascular parkinsonism, post-encephalitis parkinsonism, or any other non-primary Parkinson's disease;\"\n* Into the group 2 months before taking any probiotics and prebiotics (including lactulose) or antibiotics\n* Adjustment of Parkinson's disease medication within 1 month before enrollment; In group 1 month before taking clonazepam and benzodiazepines medicine melatonin, etc.\n* With the following diseases, including but not limited to obstructive sleep apnea syndrome, Alzheimer disease, malignant tumor, spinal cord lesions, epilepsy, autonomic nerve disease (urinary retention, urinary incontinence or orthostatic hypotension, vertical drop in blood pressure in five minutes more than 30\u002F15 MMHG), etc.; 3 month new cerebrovascular disease or severe cerebrovascular disease sequela, impact assessment;\n* Patients with severe anxiety or depression or under drug treatment;\n* Severe cardiovascular diseases (such as congestive heart failure with American Heart Association functional class Ⅲ-Ⅳ, history of myocardial infarction within 6 months, etc.);\n* Severe liver and kidney dysfunction, cereal third transaminase, aspertate aminotransferase, total bilirubin is higher than the upper limit of normal value of 1. 5 times; The serum creatinine was higher than the upper limit of the normal range. 5 times;\n* Pregnant and lactating women or pregnant women aged 40-60 years with positive HCG;\n* Known to be allergic to Bifidobacterium triple viable capsules, Bacillus licheniformis, or their excipients;\n* With a history of drug abuse or alcohol dependence\n* Were enrolled in another clinical trial at enrollment;\n* Refused into groups, and can cooperate with researchers; Patients who were judged by the investigator to be ineligible for enrollment.\n\nHealthy subjects exclusion criteria:\n\n* Patients with Parkinson's disease motor symptoms and met the diagnosis of parkinsonism were included in PD-RBD group; \"Parkinsonism plus syndrome and secondary parkinsonism, such as multiple system atrophy, progressive supranuclear palsy, cortical basal ganglia degeneration, dementia with Lewy bodies, vascular parkinsonism, post-encephalitis parkinsonism, or any other non-primary Parkinson's disease;\" 2) taking any probiotics or prebiotics (including lactulose) or antibiotics within 2 months before enrollment; 1 month before the 3) into the group of Parkinson's disease medication adjustment; Benzodiazepines such as clonazepam and melatonin were taken within 1 month before enrollment. 4) combined with the following diseases, including but not limited to obstructive sleep apnea syndrome, Alzheimer's disease, malignant tumors, spinal cord lesions, epilepsy, autonomic disorders (urinary retention, urinary incontinence or orthostatic hypotension, blood pressure drop more than 30\u002F15 MMHG after 5 minutes of standing), etc.; New onset of cerebrovascular disease or severe sequelae of cerebrovascular disease within 3 months, affecting the assessment\n* Patients with severe anxiety or depression or under drug treatment;\n* Severe cardiovascular diseases (such as congestive heart failure with American Heart Association functional class Ⅲ-Ⅳ, history of myocardial infarction within 6 months, etc.)\n* Severe liver and kidney dysfunction, cereal third transaminase, aspertate aminotransferase, total bilirubin is higher than the upper limit of normal value of 1. 5 times; The serum creatinine was higher than the upper limit of the normal range. 5 times\n* Pregnant and lactating women or pregnant women aged 40-60 years with positive HCG; 9) known to the bifidobacterium triple viable capsules, bacillus licheniformis, or its accessories, and other allergies;\n* With a history of drug abuse or alcohol dependence\n* Were enrolled in another clinical trial at enrollment;\n* Refused into groups, and can cooperate with researchers; The researchers judgment for doesn't fit into the group of patients.",true,"ALL","40 Years","85 Years",{"count":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","Rapid eye movement sleep behavior disorder (RBD) is important non-movement feature, and also the important risk factor of Parkinson's disease (PD). In our previous work, we found that the movement features and RBD of PD patients improved after taking probiotics. The later was not reported before and the mechanism not clear. To investigate its role and mechanism, we plan to enroll patients of PD-RBD, idiopathic RBD, and healthy control, collect data of multimodal image technology before and after probiotic treatment，including resting state functional MRI，1H-MRS，123I-MIBG; analyze these data with clinical features, including UPDRS -III score, RBD-HK score , as well as the bacteria abundance and level of glutamate，GABA in blood and stool. Then, construct PD mouse model by fecal transplantation of PD patient, give or not give mouse probiotics treatment, and detect the level of glutamate, GABA, and so on, as well as α-synuclein of each brain area of each group, to explore the role and mechanism of probiotics in improving RBD and movement disorder of PD.",[28,29,30,31,32,33],"Parkinson Disease","Movement Disorders","Rapid Eye Movement Sleep Behavior Disorder","Gut Microbiomes","Magnetic Resonance Imaging (MRI)","Probiotic",[33,35,30,36],"Parkinson's disease","Multimodel Magnetic Resonance Imaging","RECRUITING","2024-11-29",{"date":40,"type":41},"2024-12-02","ACTUAL",{"date":43,"type":41},"2022-09-01",{"date":45,"type":22},"2025-06-30",{"name":47,"class":48},"Beijing Friendship Hospital","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100562688","effect-of-acupuncture-for-rapid-eye-movement-sleep-behavior-disorder-100562688","NCT06606418","Effect of Acupuncture for Rapid Eye Movement Sleep Behavior Disorder","Effect of Acupuncture for Rapid Eye Movement Sleep Behavior Disorder : a Randomized Controlled Trial","Inclusion Criteria:\n\n* (1) Patients who meet the diagnostic criteria of ICSD-3. To confirm this diagnosis, one of the following conditions must be met: ① The diagnosis is RBD after previous vPSG examination. ② Those who have not been diagnosed should fill in RBDQ-HK. If the score is greater than 20, it indicates possible RBD, and accept vPSG test to confirm the diagnosis.\n* (2)Patients belong to iRBD or secondary to the following three alpha-synuclein diseases: Parkinson\\'s disease\u002Fmultiple system atrophy\u002FLewy body dementia;\n* (3) ≥18 years of age, male or female;\n* (4) At least 2 episodes of RBD events in the past 2 weeks (recalled by the patient or described by family members), including: ① verbal behavior, such as Shouting and swearing; ② Physical movement behavior, such as waving arms, punching and kicking; ③Falling out of bed, dropping things around you, injuring yourself or others, which is speculated to be related to dreaming behavior;\n* (5) Volunteer subjects and sign informed consent;\n* (6) Can cooperate with the completion of this study.\n\nExclusion Criteria:\n\n* (1) During pregnancy or lactation;\n* (2) Patients with secondary RBD associated with narcolepsy or antidepressant use;\n* (3) Patients with severe anxiety, depression and other mental diseases, alcohol abuse and\u002For psychoactive drug use, drug abusers and dependents;\n* (4) Patients with serious underlying diseases, especially unstable diseases (such as malignant tumors, chronic obstructive pulmonary disease, unstable heart disease, etc.);\n* (5) Patients with coagulation dysfunction, skin infection or damage at the surgical site should not receive acupuncture.","18 Years",{"count":59,"type":22},30,[61],"NA","Rapid eye movement (REM) sleep behaviour disorder (RBD) is a parasomnia that is characterized by abnormal behaviours occurring during REM sleep（a sleep stage）, often as dream enactments that can cause injury. Treatment options are limited. Pharmacological treatments include melatonin and clonazepam, but they have varying degrees of adverse reactions. Acupuncture is a green and safe means of treatment and has therapeutic value in sleep disorders. Using the theory of traditional Chinese medicine, the acupuncture treatment of RBD group points was formulated, and good clinical effect was obtained in the early clinical practice.This study was designed to explore the clinical efficacy of acupuncture in the treatment of RBD. Thirty patients with RBD who met the inclusion and exclusion criteria were randomly divided into acupuncture group and sham acupuncture group, and were subjected to a 2-week screening period, a 4-week treatment period, and a 2-week follow-up period.The investigators will primarily observe whether there is a reduction in the number of weekly RBD events recorded by the wCIRUS-RBD questionnaire before and after treatment, and the reduction in the RWA index recorded by video polysomnography (vPSG).",[30],[65,66,67,68],"Rapid eye movement sleep behaviour disorder(RBD)","acupuncture","randomized controlled trial","clinical research","NOT_YET_RECRUITING","2024-09-20",{"date":72,"type":41},"2024-09-23",{"date":74,"type":22},"2024-09-25",{"date":76,"type":22},"2025-04-30",{"name":78,"class":48},"Beijing Hospital of Traditional Chinese Medicine"]