Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606418
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Effect of Acupuncture for Rapid Eye Movement Sleep Behavior Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Acupuncture for Rapid Eye Movement Sleep Behavior Disorder a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rapid eye movement REM sleep behaviour disorder RBD is a parasomnia that is characterized by abnormal behaviours occurring during REM sleepa 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 practiceThis 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 periodThe 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
Detailed Description:
Rapid eye movement REM sleep behaviour disorder RBD is a parasomnia that is characterized by abnormal behaviours occurring during REM sleepa 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 practiceThis 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 periodThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None