Effect of Acupuncture for Rapid Eye Movement Sleep Behavior Disorder

Официальное название

Effect of Acupuncture for Rapid Eye Movement Sleep Behavior Disorder : a Randomized Controlled Trial

Обзор

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).

Подробное описание

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).

Вмешательства

• Другое 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 Shangqi
• Другое 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

Первичные конечные точки

• weekly CIRUS-RBD Questionnaire [Срок оценки: 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.]

Вторичные конечные точки (3)

• Pittsburgh Sleep Quality Index(PSQI) [Срок оценки: PSQI will be assessed before initiation of treatment and after 4 weeks of treatment.]
• RBD Severity Scale (RBDss) [Срок оценки: Assessment will be performed before initiation of treatment and after 4 weeks of treatment.]
• RWA index [Срок оценки: Assessment will be performed before initiation of treatment and after 4 weeks of treatment]

Критерии участия

Критерии включения

• (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.
• (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.

Критерии исключения

• (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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06606418 · 2024BL02-085-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗