Effect of Acupuncture for Rapid Eye Movement Sleep Behavior Disorder
NCT06606418 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2024-09-23
Summary
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).
Conditions
- Rapid Eye Movement Sleep Behavior Disorder
Interventions
- OTHER
-
Acupuncture group
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.
- OTHER
-
Sham acupuncture group
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.
Sponsors & Collaborators
-
Beijing Hospital of Traditional Chinese Medicine
lead OTHER
Principal Investigators
-
Huanqin Li, Physician · Beijing University of Chinese Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-25
- Primary Completion
- 2025-04-15
- Completion
- 2025-04-30
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