Effect of Acupuncture for Rapid Eye Movement Sleep Behavior Disorder : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- weekly CIRUS-RBD Questionnaire
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Patients who meet the diagnostic criteria of ICSD-
- •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.
- •(2)Patients belong to iRBD or secondary to the following three alpha-synuclein diseases: Parkinson's disease/multiple system atrophy/Lewy body dementia;
- •(3) ≥18 years of age, male or female;
- •(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;
- •(5) Volunteer subjects and sign informed consent;
- •(6) Can cooperate with the completion of this study.
排除标准
- •(1) During pregnancy or lactation;
- •(2) Patients with secondary RBD associated with narcolepsy or antidepressant use;
- •(3) Patients with severe anxiety, depression and other mental diseases, alcohol abuse and/or psychoactive drug use, drug abusers and dependents;
- •(4) Patients with serious underlying diseases, especially unstable diseases (such as malignant tumors, chronic obstructive pulmonary disease, unstable heart disease, etc.);
- •(5) Patients with coagulation dysfunction, skin infection or damage at the surgical site should not receive acupuncture.
结局指标
主要结局
weekly CIRUS-RBD Questionnaire
时间窗: 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.
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.
次要结局
- 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)
研究者
Wang Ziyi
Physician
Beijing Hospital of Traditional Chinese Medicine