Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-03-03 @ 12:10 PM
Study NCT ID:
NCT06606418
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-23
First Post:
2024-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Acupuncture for Rapid Eye Movement Sleep Behavior Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020187', 'term': 'REM Sleep Behavior Disorder'}], 'ancestors': [{'id': 'D020923', 'term': 'REM Sleep Parasomnias'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-20', 'studyFirstSubmitDate': '2024-09-18', 'studyFirstSubmitQcDate': '2024-09-18', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weekly CIRUS-RBD Questionnaire', 'timeFrame': 'Patients will be required to complete the wCIRUS-RBDQ questionnaire for a total of 8 weeks from the beginning of the screening period to the end of the follow-up period of 2 weeks after the end of treatment.', 'description': 'The wCIRUS-RBDQ (weekly CIRUS-RBD Questionnaire) is used to record RBD-related information of patients every night of the week, and to be recalled and recorded by the patient and/or bed partner the next morning. Includes 4 items: (1) whether others know about your sleep; (2) Sleeping time; (3) whether there are vivid dreams, and if so, the frequency and severity of the dreams; (4) whether there is a dream deduction act, if so, what it is and how many times; The average weekly frequency of RBD events calculated in Part 4 of the questionnaire was used as the main outcome indicator. A higher frequency of RBD events means a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Pittsburgh Sleep Quality Index(PSQI)', 'timeFrame': 'PSQI will be assessed before initiation of treatment and after 4 weeks of treatment.', 'description': 'The Pittsburgh Sleep Quality Index (PSQI) is an international sleep assessment scale used to determine whether a person has sleep quality problems and their severity.The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. PSQI total score ≥7 points, can be judged as having sleep quality problems, PSQI score 7-11 points for mild, PSQI score 12-16 points for moderate, PSQI score 17-21 points for severe.'}, {'measure': 'RBD Severity Scale (RBDss)', 'timeFrame': 'Assessment will be performed before initiation of treatment and after 4 weeks of treatment.', 'description': 'The RBDss scale based on vPSG can be used to assess the RBD events and their severity, including motor events and vocal events. The results of RBDSS are divided into 8 points (0-3.5 points). Higher scores mean a worse outcome.'}, {'measure': 'RWA index', 'timeFrame': 'Assessment will be performed before initiation of treatment and after 4 weeks of treatment', 'description': 'REM sleep hypertonia (RWA) is the characteristic manifestation of BRD recorded by polysomngraphy (vPSG). The interpretation follows the AASM2.6 interpretation standard. The RWA index (The ratio of RWA frames to REM frames) can be detected by vPSG. Higher RWA index means a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rapid eye movement sleep behaviour disorder(RBD)', 'acupuncture', 'randomized controlled trial', 'clinical research'], 'conditions': ['Rapid Eye Movement Sleep Behavior Disorder']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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 as a randomized, controlled and single-blind trial 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/multiple system atrophy/Lewy 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/or 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.'}, 'identificationModule': {'nctId': 'NCT06606418', 'briefTitle': 'Effect of Acupuncture for Rapid Eye Movement Sleep Behavior Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Hospital of Traditional Chinese Medicine'}, 'officialTitle': 'Effect of Acupuncture for Rapid Eye Movement Sleep Behavior Disorder : a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2024BL02-085-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acupuncture group', 'description': 'The patients in this group received acupuncture treatment.', 'interventionNames': ['Other: Acupuncture group']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham acupuncture group', 'description': 'The patients in this group received sham acupuncture treatment.', 'interventionNames': ['Other: Sham acupuncture group']}], 'interventions': [{'name': 'Acupuncture group', 'type': 'OTHER', 'description': 'The patients in this group received acupuncture treatment 3 times a week for 4 weeks. Acupuncture points selection: bilateral Fei Shu (BL13), Xin Shu (BL15), Ji Shu (BL17), Gan Shu (BL18), PI Shu (BL20), Shen Shu (BL23), Shangqiu (SP5), Yin Bai (SP5), foot Qioyin (GB44), Li Dui (ST45). Acupuncture operation method: The patient took the lateral position and used Huacheng acupuncture needle (body length 40mm, diameter 0.30mm) to skew 0.5\\~0.8 inches at the back acupoint, 0.5\\~0.8 inches at Shangqiu (SP5), 0.1 inches at Yin Bai (SP5), foot Qiaoyin (GB44) and Li Dui (ST45), and left the needle for 30 minutes to wait for qi.', 'armGroupLabels': ['Acupuncture group']}, {'name': 'Sham acupuncture group', 'type': 'OTHER', 'description': 'The patients in this group received sham acupuncture treatment 3 times a week for 4 weeks. Sham acupuncture points are selected at sham points close to the acupoints of the acupuncture group: 3 inches beside Fei Shu (BL13), Xin Shu (BL15), Ji Shu (BL17), Gan Shu (BL18), PI Shu (BL20), Shen Shu (BL23), 1 inches below Shangqiu (SP5), 0.1 inches behind the middle edge of the great toe, second toe and fourth toenail of the foot. Acupuncture operation method: The patient took the lateral position and used Huacheng acupuncture needle (body length 40mm, diameter 0.30mm) to pierce the skin shallowly, and left the needle for 30 minutes.', 'armGroupLabels': ['Sham acupuncture group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ziyi Wang', 'role': 'CONTACT', 'email': '1729644336@qq.com', 'phone': '+86-18801316757'}], 'overallOfficials': [{'name': 'Huanqin Li, Physician', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing University of Chinese Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'Beginning 3 months and ending 3 years after the publication of results', 'ipdSharing': 'YES', 'description': 'IPD used in the results publication will be shared.', 'accessCriteria': 'The IPD used in the results publication will be avalible to researchers，in which the name of the patients and other Identity information will be hidden. They can access the IPD by contact the principal investigator through e-mail.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Wang Ziyi', 'investigatorAffiliation': 'Beijing Hospital of Traditional Chinese Medicine'}}}}