Effect of Acupuncture for Rapid Eye Movement Sleep Behavior Disorder

NCT06606418 | Not Yet Recruiting

• 1 other identifier: 2024BL02-085-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Rapid eye movement sleep behaviour disorder(RBD); acupuncture; randomized controlled trial; clinical research

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• 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

Study Arms (2)

Acupuncture group

ACTIVE COMPARATOR

The patients in this group received acupuncture treatment.

Other: Acupuncture group

Sham acupuncture group

SHAM COMPARATOR

The patients in this group received sham acupuncture treatment.

Other: Sham acupuncture group

Interventions

Acupuncture group OTHER

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.

Acupuncture group

Sham acupuncture group OTHER

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.

Sham acupuncture group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Beijing Hospital of Traditional Chinese Medicine: lead

MeSH Terms

Conditions

REM Sleep Behavior Disorder

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Huanqin Li, Physician

  Beijing University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziyi Wang

CONTACT

+86-18801316757; 1729644336@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 23, 2024
• Study Start: September 25, 2024
• Primary Completion: April 15, 2025
• Study Completion: April 30, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: 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.