NCT06606418|Unknown
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Sponsor study identifier
interventional
30
0 countries
N/A
Study Start
September 25, 2024
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Primary Completion
April 15, 2025
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Study Completion
April 30, 2025
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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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 18, 2024
Actual (reported)September 23, 2024
Actual (reported)September 25, 2024
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April 15, 2025
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April 30, 2025
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weekly CIRUS-RBD Questionnaire
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.
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.
Pittsburgh Sleep Quality Index(PSQI)
PSQI will be assessed before initiation of treatment and after 4 weeks of treatment.
RBD Severity Scale (RBDss)
Assessment will be performed before initiation of treatment and after 4 weeks of treatment.
RWA index
Assessment will be performed before initiation of treatment and after 4 weeks of treatment
The patients in this group received acupuncture treatment.
The patients in this group received sham acupuncture treatment.
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.
Huanqin Li, Physician
Beijing University of Chinese Medicine
First Submitted
September 18, 2024
First Posted
September 23, 2024
Study Start
September 25, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Persons With REM Sleep Behavior Disorder (RBD)
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.
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April 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 30, 2025
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Last Updated
September 23, 2024
Record last verified: 2024-09
IPD used in the results publication will be shared.
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