Clinical trial NCT05806736: Curative Effect and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation on Sleep Disorders of PD
Official title: Study on the Efficacy and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation in the Treatment of Sleep Disorders in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: non-motor symptoms
Therapeutics
nighttime insomnia
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2023-04-10
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

(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.

Exclusion Criteria:

(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.

Primary outcomes:
measure: Changes in sleep quality, sleep efficiency of patients
timeFrame: Assessed at baseline, one day post intervention, fourteen days post intervention.
Secondary outcomes:
measure: The motor part of the Unified Parkinson's Disease Rating Scale
timeFrame: Assessed at baseline, one day post intervention, fourteen days post intervention.
measure: Changes of sleep quality scale
timeFrame: Assessed at baseline, one day post intervention, fourteen days post intervention.
measure: Changes of Rapid-eye-movement Sleep Behavior Disorder scale
timeFrame: Assessed at baseline, one day post intervention, fourteen days post intervention.
measure: Epworth sleepiness scale (ESS)
timeFrame: Assessed at baseline, one day post intervention.
measure: Hamilton Depression Scale-24 (HAMD-24)
timeFrame: Assessed at baseline, one day post intervention.
measure: Hamilton Anxiety Scale (HAMA)
timeFrame: Assessed at baseline, one day post intervention.
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Assessed at baseline, one day post intervention.
measure: Changes in ΔHbO2 concentration in the brain cortex
timeFrame: Assessed at baseline, one day post intervention.
measure: Plasma indicators
timeFrame: Assessed at baseline, one day post intervention, fourteen days post intervention.
measure: Subjective sleep assessment
timeFrame: Assessed at baseline, one day post intervention, fourteen days post
measure: Objective sleep assessment
timeFrame: Assessed at baseline, one day post intervention, fourteen days post
Other outcomes:
Locations:
city: Nanjing
country: China
facility: the First Affiliated Hospital of Nanjing Medical University
state: Jiang Su
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Kezhong Zhang
role: PRINCIPAL_INVESTIGATOR
References: