Curative Effect and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation on Sleep Disorders of PD
- Conditions
- Parkinson Disease
- Registration Number
- NCT05806736
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
(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.
(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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Changes in sleep quality, sleep efficiency of patients 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.
- Secondary Outcome Measures
Name Time Method The motor part of the Unified Parkinson's Disease Rating Scale Assessed at baseline, one day post intervention, fourteen days post intervention. The measure mainly reflects the overall severity of Parkinson's disease motor symptoms. The minimum and maximum values of the motor part of the Unified Parkinson's Disease Rating Scale are 0 and 108. A higher score means a worse outcome.
Changes of sleep quality scale Assessed at baseline, one day post intervention, fourteen days post intervention. Non-motor symptoms such as sleep disorders were evaluated by Parkinson's disease sleep scale-2 (PDSS-2). PDSS-2 is an improved version of PDSS used to screen for common types of sleep disorders in Parkinson's disease patients. The minimum and maximum values of the non-motor part of the PDSS-2 Scale are 0 and 60. A higher score means a worse outcome.
Changes of Rapid-eye-movement Sleep Behavior Disorder scale Assessed at baseline, one day post intervention, fourteen days post intervention. Rapid-eye-movement Sleep Behavior Disorder Screening Questionnaire (RBDSQ) was used to assess the behavior disorder of multiple eye movement sleep. The minimum and maximum values of the non-motor part of the RBDSQ Scale are 0 and 13. A higher score means a worse outcome.
Epworth sleepiness scale (ESS) Assessed at baseline, one day post intervention. The Epworth Sleepiness Scale, also known as the Epworth Daytime Sleepiness Scale, was developed by Johns MW to assess excessive daytime sleepiness. This scale has clinical significance: it can provide a semi-objective assessment of sleepiness. Scoring more than 6 out of 24 indicates drowsiness, more than 11 indicates excessive sleepiness, and more than 16 indicates dangerous sleepiness.
Hamilton Depression Scale-24 (HAMD-24) Assessed at baseline, one day post intervention. The Hamilton Depression Rating Scale is the most widely used instrument for clinical assessment of depressive states, effectively reflecting the severity of the condition. The total score ranges from 0 to 76 points, with lower scores indicating milder symptoms and higher scores signifying more severe conditions.
Plasma indicators Assessed at baseline, one day post intervention, fourteen days post intervention. 5ml of the patient's elbow vein blood was collected and centrifuged after standing and stratified. The blood plasma was collected and frozen at - 20 ℃ for testing. Detection of changes in plasma ghrelin levels.
Changes in ΔHbO2 concentration in the brain cortex Assessed at baseline, one day post intervention. The ΔHbO2 concentration in the brain cortex will be recorded in oxyhemoglobin.
Subjective sleep assessment Assessed at baseline, one day post intervention, fourteen days post Using sleep logs to record participants' subjective sleep data, including subjective sleep quality scores，early morning refreshment scores, easy wake up scores, ease of falling asleep scores, and dreaming scores.
Objective sleep assessment Assessed at baseline, one day post intervention, fourteen days post Using MI wristbands for objective sleep assessment, including deep sleep time scores，night waking up times, light sleep duration, and the REM sleep duration.
Montreal Cognitive Assessment (MoCA) Assessed at baseline, one day post intervention. The Montreal Cognitive Assessment is an evaluation tool used for rapid screening of patients with mild cognitive impairment. The assessed cognitive domains include attention and concentration, executive function, memory, language, visuospatial skills, abstract thinking, as well as calculation and orientation. The total score of the scale is 30 points, with test results indicating a normal value of ≥26 points.
Hamilton Anxiety Scale (HAMA) Assessed at baseline, one day post intervention. The Hamilton Anxiety Scale is commonly used in clinical practice as a basis for diagnosing anxiety disorders and assessing their severity. The total score can be used to evaluate the severity of anxiety symptoms in patients with anxiety and depressive disorders, as well as to assess the effects of various pharmacological and psychological interventions. According to data provided by the Chinese Scale Collaborative Group: a total score ≥29 indicates possible severe anxiety; ≥21 confirms significant anxiety; ≥14 confirms the presence of anxiety; \>7 suggests possible anxiety; and a score \<7 indicates no anxiety symptoms.
Trial Locations
- Locations (1)
the First Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiang Su, China
the First Affiliated Hospital of Nanjing Medical University🇨🇳Nanjing, Jiang Su, China