Study on the Efficacy and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation in the Treatment of Sleep Disorders in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in sleep quality, sleep efficiency of patients
研究概览
简要总结
This study is a double-blind comparative study examining the curative effect and mechanism of the transcutaneous auricular vagus nerve stimulation treatment on non-motor symptoms of Parkinson's disease patients. The investigators hypothesize that treatment using transcutaneous auricular vagus nerve stimulation will improve the non-motor symptoms, such as improving sleep, and improve cortical activity simultaneously in Parkinson's disease patients.
详细描述
Patients in the Experimental group underwent fourteen consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS, twice daily, 30 minutes each time), whereas patients in the sham stimulation group underwent fourteen consecutive daily sessions of sham taVNS. Assessments of motor and non-motor symptoms, cortical activity (using Functional near-infrared spectroscopy) and blood indicators were performed three times: at baseline, one day post intervention, fourteen days post intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(i) right-handed individuals aged 45-80 years; (ii) met the diagnostic criteria for idiopathic PD and had been stable on medication for at least one month; (iii) met the diagnostic criteria for insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, and insomnia had to have lasted for at least six months, with Pittsburgh sleep quality index (PSQI) scores >7; (iv) no history of medication that might affect the study, such as sleeping pills or antidepressants, that is, the PSQI hypnotic medication score of 0; (v) clear consciousness, basic communication skills and cooperation in all assessments and treatments; (vi) The patients agreed to participate in the study and signed an informed consent form.
排除标准
- •(i) those with concomitant cognitive dysfunction, such as Montreal cognitive assessment (MoCA) <23; (ii) those with secondary Parkinson's syndrome or Parkinson's superimposed syndrome; (iii) those with severe cardiac, pulmonary, hepatic, renal, or concomitant malignancies or a history of previous brain surgery; (iv) those with contraindications to taVNS interventions; (v) those with severe psychiatric disorders; (vi) Insomnia not caused by PD, such as frequent (two times per week) nighttime use of sedative medications (including sedative antidepressants), untreated restless legs syndrome, night-shift work or other occupations that result in abnormal sleep patterns, insomnia associated with dopamine therapy, and other reversible causes of insomnia identified by the baseline clinical interview.
研究组 & 干预措施
active transcutaneous auricular vagus nerve stimulatio
For Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent fourteen consecutive daily sessions of taVNS.
干预措施: Transcutaneous auricular vagus nerve stimulation (real stimulation) (Device)
sham transcutaneous auricular vagus nerve stimulation
For sham transcutaneous auricular vagus nerve stimulation arm, Sham Comparator, patients underwent fourteen consecutive daily sessions of sham-taVNS (the electrodes were fixed at the left earlobe with the same stimulation parameters).
干预措施: Transcutaneous auricular vagus nerve stimulation (sham stimulation) (Device)
结局指标
主要结局
Changes in sleep quality, sleep efficiency of patients
时间窗: Assessed at baseline, one day post intervention, fourteen days post intervention.
Pittsburgh sleep quality index (PSQI) was used to evaluate the sleep quality of participants in the past month. It consists of 19 self-evaluation and 5 other evaluation items. The total score range is 0-21, with higher scores indicating poorer sleep quality.
次要结局
- The motor part of the Unified Parkinson's Disease Rating Scale(Assessed at baseline, one day post intervention, fourteen days post intervention.)
- Changes of sleep quality scale(Assessed at baseline, one day post intervention, fourteen days post intervention.)
- Changes of Rapid-eye-movement Sleep Behavior Disorder scale(Assessed at baseline, one day post intervention, fourteen days post intervention.)
- Epworth sleepiness scale (ESS)(Assessed at baseline, one day post intervention.)
- Montreal Cognitive Assessment (MoCA)(Assessed at baseline, one day post intervention.)
- Hamilton Depression Scale-24 (HAMD-24)(Assessed at baseline, one day post intervention.)
- Hamilton Anxiety Scale (HAMA)(Assessed at baseline, one day post intervention.)
- Changes in ΔHbO2 concentration in the brain cortex(Assessed at baseline, one day post intervention.)
- Plasma indicators(Assessed at baseline, one day post intervention, fourteen days post intervention.)
- Subjective sleep assessment(Assessed at baseline, one day post intervention, fourteen days post)
- Objective sleep assessment(Assessed at baseline, one day post intervention, fourteen days post)
研究者
Kezhong Zhang
professor/Chief physician
The First Affiliated Hospital with Nanjing Medical University