Protocol for a randomized controlled trial exploring the brain mechanism and therapeutic effect of electroacupuncture on cognitive function and sleep quality in chronic insomnia
Abstract Background Insomnia is a prevalent sleep disorder that affects up to 15% of the population worldwide and is the second most common mental health issue. There is increasing interest in the effects of long-term insomnia on cognitive function. Electroacupuncture can effectively improve cogniti...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2023-11-01
|
| Series: | BMC Complementary Medicine and Therapies |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12906-023-04242-y |
| _version_ | 1797630475768954880 |
|---|---|
| author | Linhao Lu Lizhen Liao Jiaorong Zheng Weiyi Lin TaiShun Wang Xiuyun Wen |
| author_facet | Linhao Lu Lizhen Liao Jiaorong Zheng Weiyi Lin TaiShun Wang Xiuyun Wen |
| author_sort | Linhao Lu |
| collection | DOAJ |
| description | Abstract Background Insomnia is a prevalent sleep disorder that affects up to 15% of the population worldwide and is the second most common mental health issue. There is increasing interest in the effects of long-term insomnia on cognitive function. Electroacupuncture can effectively improve cognitive function and sleep quality, yet the underlying brain network mechanisms remain unclear. This study aims to explore the network regulatory mechanisms associated with enhanced cognitive function and sleep quality, providing theoretical support for the use of electroacupuncture in the clinical treatment of chronic insomnia. Methods This study is divided into two parts. Sixteen individuals with chronic insomnia and 16 healthy controls of similar age and gender will be recruited in Study 1 to examine the brain network topology of individuals with chronic insomnia. Study 2 will be a randomized controlled trial with 120 chronic insomnia patients divided into three groups: Group A (electroacupuncture plus placebo drug), Group B (drug plus placebo electroacupuncture), and Group C (placebo electroacupuncture plus placebo drug). Participants will be exposed to 24 treatments over an 8-week period (3 times per week) and monitored for 12 additional weeks. The primary outcome measure will be changes in brainwave data from before to after the treatment. In addition, the Wisconsin Card Sorting Test and the Pittsburgh Sleep Quality Index will be utilized as secondary outcomes to measure from before to after treatment and during the follow-up. A correlation analysis will be conducted to explore links among modifications in brainwave patterns, Wisconsin Card Sorting Test scores, and Pittsburgh Sleep Quality Index scores. Additionally, any adverse events will be strictly monitored. Discussion Electroacupuncture may represent an alternative treatment for chronic insomnia, and this trial is expected to reveal the brain mechanism by which electroacupuncture improves cognitive function and sleep quality in chronic insomnia patients. Trial registration ChiCTR2200060150 (Chinese Clinical Trial Registry, http://www.chictr.org.cn , registered on 20 May 2022). |
| first_indexed | 2024-03-11T11:07:42Z |
| format | Article |
| id | doaj.art-a5ab568186a6462484840270f14d77ff |
| institution | Directory Open Access Journal |
| issn | 2662-7671 |
| language | English |
| last_indexed | 2024-03-11T11:07:42Z |
| publishDate | 2023-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Complementary Medicine and Therapies |
| spelling | doaj.art-a5ab568186a6462484840270f14d77ff2023-11-12T12:06:42ZengBMCBMC Complementary Medicine and Therapies2662-76712023-11-012311810.1186/s12906-023-04242-yProtocol for a randomized controlled trial exploring the brain mechanism and therapeutic effect of electroacupuncture on cognitive function and sleep quality in chronic insomniaLinhao Lu0Lizhen Liao1Jiaorong Zheng2Weiyi Lin3TaiShun Wang4Xiuyun Wen5School of Health Science, Guangdong Pharmaceutical UniversitySchool of Health Science, Guangdong Pharmaceutical UniversitySchool of Health Science, Guangdong Pharmaceutical UniversitySchool of Health Science, Guangdong Pharmaceutical UniversitySchool of Health Science, Guangdong Pharmaceutical UniversitySchool of Health Science, Guangdong Pharmaceutical UniversityAbstract Background Insomnia is a prevalent sleep disorder that affects up to 15% of the population worldwide and is the second most common mental health issue. There is increasing interest in the effects of long-term insomnia on cognitive function. Electroacupuncture can effectively improve cognitive function and sleep quality, yet the underlying brain network mechanisms remain unclear. This study aims to explore the network regulatory mechanisms associated with enhanced cognitive function and sleep quality, providing theoretical support for the use of electroacupuncture in the clinical treatment of chronic insomnia. Methods This study is divided into two parts. Sixteen individuals with chronic insomnia and 16 healthy controls of similar age and gender will be recruited in Study 1 to examine the brain network topology of individuals with chronic insomnia. Study 2 will be a randomized controlled trial with 120 chronic insomnia patients divided into three groups: Group A (electroacupuncture plus placebo drug), Group B (drug plus placebo electroacupuncture), and Group C (placebo electroacupuncture plus placebo drug). Participants will be exposed to 24 treatments over an 8-week period (3 times per week) and monitored for 12 additional weeks. The primary outcome measure will be changes in brainwave data from before to after the treatment. In addition, the Wisconsin Card Sorting Test and the Pittsburgh Sleep Quality Index will be utilized as secondary outcomes to measure from before to after treatment and during the follow-up. A correlation analysis will be conducted to explore links among modifications in brainwave patterns, Wisconsin Card Sorting Test scores, and Pittsburgh Sleep Quality Index scores. Additionally, any adverse events will be strictly monitored. Discussion Electroacupuncture may represent an alternative treatment for chronic insomnia, and this trial is expected to reveal the brain mechanism by which electroacupuncture improves cognitive function and sleep quality in chronic insomnia patients. Trial registration ChiCTR2200060150 (Chinese Clinical Trial Registry, http://www.chictr.org.cn , registered on 20 May 2022).https://doi.org/10.1186/s12906-023-04242-yElectroacupunctureChronic insomniaClinical trialRandomized controlled trialBrain mechanism |
| spellingShingle | Linhao Lu Lizhen Liao Jiaorong Zheng Weiyi Lin TaiShun Wang Xiuyun Wen Protocol for a randomized controlled trial exploring the brain mechanism and therapeutic effect of electroacupuncture on cognitive function and sleep quality in chronic insomnia BMC Complementary Medicine and Therapies Electroacupuncture Chronic insomnia Clinical trial Randomized controlled trial Brain mechanism |
| title | Protocol for a randomized controlled trial exploring the brain mechanism and therapeutic effect of electroacupuncture on cognitive function and sleep quality in chronic insomnia |
| title_full | Protocol for a randomized controlled trial exploring the brain mechanism and therapeutic effect of electroacupuncture on cognitive function and sleep quality in chronic insomnia |
| title_fullStr | Protocol for a randomized controlled trial exploring the brain mechanism and therapeutic effect of electroacupuncture on cognitive function and sleep quality in chronic insomnia |
| title_full_unstemmed | Protocol for a randomized controlled trial exploring the brain mechanism and therapeutic effect of electroacupuncture on cognitive function and sleep quality in chronic insomnia |
| title_short | Protocol for a randomized controlled trial exploring the brain mechanism and therapeutic effect of electroacupuncture on cognitive function and sleep quality in chronic insomnia |
| title_sort | protocol for a randomized controlled trial exploring the brain mechanism and therapeutic effect of electroacupuncture on cognitive function and sleep quality in chronic insomnia |
| topic | Electroacupuncture Chronic insomnia Clinical trial Randomized controlled trial Brain mechanism |
| url | https://doi.org/10.1186/s12906-023-04242-y |
| work_keys_str_mv | AT linhaolu protocolforarandomizedcontrolledtrialexploringthebrainmechanismandtherapeuticeffectofelectroacupunctureoncognitivefunctionandsleepqualityinchronicinsomnia AT lizhenliao protocolforarandomizedcontrolledtrialexploringthebrainmechanismandtherapeuticeffectofelectroacupunctureoncognitivefunctionandsleepqualityinchronicinsomnia AT jiaorongzheng protocolforarandomizedcontrolledtrialexploringthebrainmechanismandtherapeuticeffectofelectroacupunctureoncognitivefunctionandsleepqualityinchronicinsomnia AT weiyilin protocolforarandomizedcontrolledtrialexploringthebrainmechanismandtherapeuticeffectofelectroacupunctureoncognitivefunctionandsleepqualityinchronicinsomnia AT taishunwang protocolforarandomizedcontrolledtrialexploringthebrainmechanismandtherapeuticeffectofelectroacupunctureoncognitivefunctionandsleepqualityinchronicinsomnia AT xiuyunwen protocolforarandomizedcontrolledtrialexploringthebrainmechanismandtherapeuticeffectofelectroacupunctureoncognitivefunctionandsleepqualityinchronicinsomnia |