Status:
NOT_YET_RECRUITING
Effect of Acupuncture for Rapid Eye Movement Sleep Behavior Disorder
Lead Sponsor:
Beijing Hospital of Traditional Chinese Medicine
Conditions:
Rapid Eye Movement Sleep Behavior Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- (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.
Exclusion
- (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.
Key Trial Info
Start Date :
September 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06606418
Start Date
September 25 2024
End Date
April 30 2025
Last Update
September 23 2024
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