Acupuncture for patients with insomnia disorder using resting-state functional magnetic resonance imaging: a protocol for a Randomised Controlled Trial

Abstract Background Insomnia is among the most prevalent of the sleep-related disorders. Insomnia disorder is associated with a brain hyperarousal state manifested by abnormal regional brain activity and resting state functional connectivity. Acupuncture improves sleep quality and modulates the hyperarousal state; however, the underlying neurobiological basis for improved sleep quality is poorly understood. The purpose of this clinical trial is to study the efficacy of acupuncture in the treatment of insomnia disorder. In addition, the neural mechanism by which acupuncture affects insomnia disorder will be explored using resting-state functional magnetic resonance imaging (rs-fMRI) and neuropsychological parameters. Methods and design A randomized, patient- and assessor-blinded trial will be conducted. We will randomize (in a 1:1 ratio) 60 eligible patients with insomnia disorder into a real acupuncture group or a sham acupuncture group. Interventions will be administered three times per week over a 4-week period, with an 8-week follow-up period. The healthy control group will consist of 30 age- and sex-matched healthy individuals who sleep well without any treatment intervention. All participants will undergo neuropsychological and rs-fMRI evaluations. The change in Pittsburgh Sleep Quality Index (PSQI) scores is the primary outcome parameter. The secondary outcome parameters include the Hyperarousal scale (HAS), rs-fMRI measurements, the Fatigue scale-14 (FS-14), the Hamilton depression scale (HAMD), the Hamilton anxiety scale (HAMA), a sleep diary, and an actigraph. Assessment of all parameters will be performed at baseline, post-treatment, and during follow-up. Analyses will be implemented based on intention-to-treat. Discussion The study results will be used to clarify the effectiveness and elucidate the mechanism by which acupuncture improves sleep quality in patients with insomnia disorder. Trial registration Chinese Clinical Trials Register, ChiCTR1800015282. Registered on 20 March 2018.

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Acupuncture for patients with insomnia disorder protocol for a resting-state functional magnetic resonance imaging study

10.21203/rs.2.384/v1 ◽

2019 ◽

Author(s):

Jing Guo ◽

Siyi Yu ◽

Chunhong Liu ◽

Guiling Wang ◽

Bin li

Keyword(s):

Magnetic Resonance Imaging ◽

Magnetic Resonance ◽

Functional Magnetic Resonance Imaging ◽

Sleep Quality ◽

Resting State ◽

Acupuncture Group ◽

Secondary Outcome ◽

Functional Magnetic Resonance ◽

Resonance Imaging ◽

Insomnia Disorder

Abstract Background Insomnia is among the most prevalent sleep-related disorders. Previous researches suggest insomnia disorder is associated with brain hyperarousal state manifested as abnormal regional brain activity and resting-state functional connectivity (rs-FC). Acupuncture is considered to be beneficial to improve sleep quality and modulate hyperarousal state. Its underlying neurobiological bases remain poorly understood. The purpose of the trial is to investigate the effectiveness and potential neural mechanism in acupuncture treatment for insomnia disorder using neuropsychological measurements and resting-state functional magnetic resonance imaging (rs-fMRI). Methods /Design This study is a randomized, patient-assessor-blinded trial. A total of 60 eligible patients with insomnia disorder will be randomized in a ratio of 1:1 to the real acupuncture group and sham acupuncture group. Acupuncture intervention will be administered to all patients three times a week for 4 weeks, followed up for 8 weeks. 30 age- and sex-matched healthy good sleepers will be recruited as healthy control group without any treatment intervention. All participants will undergo neuropsychological and rs-fMRI evaluations. The primary outcome includes the change of Pittsburgh Sleep Quality Index (PSQI) scores. The secondary outcome includes Hyperarousal scale (HAS),rs-fMRI measurements, Fatigue scale-14 (FS-14), Hamilton depression scale (HAMD), Hamilton anxiety scale (HAMA), a sleep diary, and actigraph test. All outcomes will be evaluated at baseline, post-treatment period and follow-up. The main analyses will be carried out on the basis of the intention-to-treat principle. Discussion The results of the trial will contribute to the efficacy and central mechanism of acupuncture treating insomnia disorder.

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Acupuncture for patients with insomnia disorder protocol for a resting-state functional magnetic resonance imaging study

10.21203/rs.2.384/v2 ◽

2019 ◽

Author(s):

Jing Guo ◽

Siyi Yu ◽

Chunhong Liu ◽

Guiling Wang ◽

Bin li

Keyword(s):

Magnetic Resonance Imaging ◽

Magnetic Resonance ◽

Functional Magnetic Resonance Imaging ◽

Sleep Quality ◽

Resting State ◽

Acupuncture Group ◽

Secondary Outcome ◽

Functional Magnetic Resonance ◽

Resonance Imaging ◽

Insomnia Disorder

Abstract Background Insomnia is among the most prevalent sleep-related disorders. Previous researches suggest insomnia disorder is associated with brain hyperarousal state manifested as abnormal regional brain activity and resting-state functional connectivity (rs-FC). Acupuncture is considered to be beneficial to improve sleep quality and modulate hyperarousal state. Its underlying neurobiological bases remain poorly understood. The purpose of the trial is to investigate the effectiveness and potential neural mechanism in acupuncture treatment for insomnia disorder using neuropsychological measurements and resting-state functional magnetic resonance imaging (rs-fMRI). Methods /Design This study is a randomized, patient-assessor-blinded trial. A total of 60 eligible patients with insomnia disorder will be randomized in a ratio of 1:1 to the real acupuncture group and sham acupuncture group. Acupuncture intervention will be administered to all patients three times a week for 4 weeks, followed up for 8 weeks. 30 age- and sex-matched healthy good sleepers will be recruited as healthy control group without any treatment intervention. All participants will undergo neuropsychological and rs-fMRI evaluations. The primary outcome includes the change of Pittsburgh Sleep Quality Index (PSQI) scores. The secondary outcome includes Hyperarousal scale (HAS),rs-fMRI measurements, Fatigue scale-14 (FS-14), Hamilton depression scale (HAMD), Hamilton anxiety scale (HAMA), a sleep diary, and actigraph test. All outcomes will be evaluated at baseline, post-treatment period and follow-up. The main analyses will be carried out on the basis of the intention-to-treat principle. Discussion The results of the trial will contribute to the efficacy and central mechanism of acupuncture treating insomnia disorder.

Download Full-text