Parkinson DiseaseNCT05806736
Curative Effect and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation on Sleep Disorders of PD
A study testing Transcutaneous auricular vagus nerve stimulation (real stimulation) in people with Parkinson Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Transcutaneous auricular vagus nerve stimulation (real stimulation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: Study on the Efficacy and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation in the Treatment of Sleep Disorders in Parkinson's Disease
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Transcutaneous auricular vagus nerve stimulation (real stimulation), Transcutaneous auricular vagus nerve stimulation (sham stimulation)
- Keywords
- non-motor symptoms, Therapeutics, nighttime insomnia
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous auricular vagus nerve stimulation (real stimulation)Device
Transcutaneous auricular vagus nerve stimulation was conducted by transcutaneous electrical stimulation therapy instrument to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve. Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs, twice a day, 30 minutes each time.
Transcutaneous auricular vagus nerve stimulation (sham stimulation)Device
Transcutaneous auricular vagus nerve stimulation was conducted by transcutaneous electrical stimulation therapy instrument to the left earlobe. Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs, twice a day, 30 minutes each time.
| Study group | Role | What they receive |
|---|---|---|
| active transcutaneous auricular vagus nerve stimulatio | Experimental | For Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent fourteen consecutive daily sessions of taVNS. Receives: Device: Transcutaneous auricular vagus nerve stimulation (real stimulation) |
| sham transcutaneous auricular vagus nerve stimulation | Sham comparator | 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). Receives: Device: Transcutaneous auricular vagus nerve stimulation (sham stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in sleep quality, sleep efficiency of patients
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.
Measured: Assessed at baseline, one day post intervention, fourteen days post intervention.
Secondary outcomes (11)
The motor part of the Unified Parkinson's Disease Rating Scale
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.
Measured: Assessed at baseline, one day post intervention, fourteen days post intervention.
Changes of sleep quality scale
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.
Measured: Assessed at baseline, one day post intervention, fourteen days post intervention.
Changes of Rapid-eye-movement Sleep Behavior Disorder scale
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.
Measured: Assessed at baseline, one day post intervention, fourteen days post intervention.
Epworth sleepiness scale (ESS)
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.
Measured: Assessed at baseline, one day post intervention.
Hamilton Depression Scale-24 (HAMD-24)
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.
Measured: Assessed at baseline, one day post intervention.
Hamilton Anxiety Scale (HAMA)
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.
Measured: Assessed at baseline, one day post intervention.
Montreal Cognitive Assessment (MoCA)
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.
Measured: Assessed at baseline, one day post intervention.
Changes in ΔHbO2 concentration in the brain cortex
The ΔHbO2 concentration in the brain cortex will be recorded in oxyhemoglobin.
Measured: Assessed at baseline, one day post intervention.
Plasma indicators
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.
Measured: Assessed at baseline, one day post intervention, fourteen days post intervention.
Subjective sleep assessment
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.
Measured: Assessed at baseline, one day post intervention, fourteen days post
Objective sleep assessment
Using MI wristbands for objective sleep assessment, including deep sleep time scores，night waking up times, light sleep duration, and the REM sleep duration.
Measured: Assessed at baseline, one day post intervention, fourteen days post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 Sep 2022
- Primary completion8 Aug 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Kezhong Zhang, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Kezhong Zhang, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806736
- Sponsor's protocol ID
- 2022-SR-519
- Status last verified
- Jun 2025
- First submitted
- 27 Feb 2023
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation in the Treatment of Sleep Disorders in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05806736
- Acronym / sponsor ID
- 2022-SR-519
- Conditions
- Parkinson Disease
- Keywords
- non-motor symptoms, Therapeutics, nighttime insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active transcutaneous auricular vagus nerve stimulatio | Experimental | Device: Transcutaneous auricular vagus nerve stimulation (real stimulation)For Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent fourteen consecutive daily sessions of taVNS. |
| sham transcutaneous auricular vagus nerve stimulation | Sham comparator | Device: Transcutaneous auricular vagus nerve stimulation (sham 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). |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous auricular vagus nerve stimulation (real stimulation)Transcutaneous auricular vagus nerve stimulation was conducted by transcutaneous electrical stimulation therapy instrument to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve. Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs, twice a day, 30 minutes each time. | Device | active transcutaneous auricular vagus nerve stimulatio |
| Transcutaneous auricular vagus nerve stimulation (sham stimulation)Transcutaneous auricular vagus nerve stimulation was conducted by transcutaneous electrical stimulation therapy instrument to the left earlobe. Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs, twice a day, 30 minutes each time. | Device | sham transcutaneous auricular vagus nerve stimulation |
Primary outcome
Changes in sleep quality, sleep efficiency of patients
Time frame: 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.
11 secondary outcomes
The motor part of the Unified Parkinson's Disease Rating Scale
Time frame: Assessed at baseline, one day post intervention, fourteen days post intervention.
Changes of sleep quality scale
Time frame: Assessed at baseline, one day post intervention, fourteen days post intervention.
Changes of Rapid-eye-movement Sleep Behavior Disorder scale
Time frame: Assessed at baseline, one day post intervention, fourteen days post intervention.
Epworth sleepiness scale (ESS)
Time frame: Assessed at baseline, one day post intervention.
Hamilton Depression Scale-24 (HAMD-24)
Time frame: Assessed at baseline, one day post intervention.
Hamilton Anxiety Scale (HAMA)
Time frame: Assessed at baseline, one day post intervention.
Montreal Cognitive Assessment (MoCA)
Time frame: Assessed at baseline, one day post intervention.
Changes in ΔHbO2 concentration in the brain cortex
Time frame: Assessed at baseline, one day post intervention.
Plasma indicators
Time frame: Assessed at baseline, one day post intervention, fourteen days post intervention.
Subjective sleep assessment
Time frame: Assessed at baseline, one day post intervention, fourteen days post
Objective sleep assessment
Time frame: Assessed at baseline, one day post intervention, fourteen days post
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kezhong Zhang principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous auricular vagus nerve stimulation (real stimulation) in people with Parkinson Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in sleep quality, sleep efficiency of patients (time frame: Assessed at baseline, one day post intervention, fourteen days post intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.