InsomniaNCT07899957
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Insomnia During the Withdrawal-Rehabilitation Period of Methamphetamine Use Disorder
A study testing taVNS in people with Insomnia, run by The First Affiliated Hospital of Zhejiang Chinese Medical University.
Trial summary
The Department of Acupuncture-Moxibustion, the First Affiliated Hospital of Zhejiang Chinese Medical University is conducting a clinical research project entitled "Randomized Controlled Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation (transcutaneous auricular vagus nerve stimulation，taVNS) for… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia
- What is being tested?
- taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years, with no gender restriction.
- Meet the diagnostic criteria for amphetamine-type stimulant use disorder as defined by the *Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision* (DSM-5-TR).
- Methamphetamine is confirmed as the sole primary substance of use based on rehabilitation records, clinical history interviews and laboratory test data.
- Participants are in the abstinence rehabilitation phase. The interval since last methamphetamine use is ≥ 2 weeks, or acute intoxication and acute withdrawal reactions are judged to be substantially stable by investigators. No severe acute intoxication, delirium, or physically/psychiatrically unstable status requiring urgent management occurs within the preceding 2 weeks.
- Meet the diagnostic criteria for insomnia disorder, with insomnia symptoms lasting ≥ 3 months and a total Insomnia Severity Index (ISI) score ≥15.
- For participants taking antidepressants, anxiolytics, antipsychotics, sedative-hypnotics or other medications potentially affecting sleep or mood, dosages remain stable for at least 4 weeks before enrollment, and no active dose adjustment is allowed during the study.
- Voluntarily agree to participate in the study and provide written informed consent.
Who cannot join
- The primary substance of use is not methamphetamine, or there exists comorbid use disorders for opioids, ketamine, etomidate, dextromethorphan, alcohol or other major psychoactive substances that, in the investigators' judgment, may substantially confound assessments of sleep, mood, craving or heart rate variability (HRV).
- Presence of ongoing acute intoxication, severe acute withdrawal, delirium, or physically/psychiatrically unstable status requiring priority clinical management.
- Current severe depression with clear suicidal ideation or plans, urgent clinical risk indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS), or recent severe self-harm or suicidal behavior.
- Acute episode of psychotic disorders, manic/mixed episodes of bipolar disorder, severe cognitive impairment, or inability to complete study assessments.
- Suspected or confirmed other sleep disorders (including obstructive sleep apnea, narcolepsy, restless legs syndrome, circadian rhythm sleep-wake disorders and parasomnias) that can explain the main insomnia symptoms, as determined by investigators.
- Severe arrhythmia, marked bradycardia, decompensated cardiopulmonary disease, severe hepatic or renal insufficiency, epilepsy, or other neurological diseases deemed unsuitable for electrical stimulation.
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- Implanted electronic devices, such as cardiac pacemakers, implantable cardioverter-defibrillators, cochlear implants, or other electronic hardware susceptible to electrical stimulation interference.
- Bilateral ear stimulation target areas with skin breakdown, infection, severe eczema, scarring, or other auricular diseases that prevent safe electrode clamping.
- Pregnant or breastfeeding women, or women who plan to become pregnant during the study.
- Participation in other interventional clinical trials or receipt of other neuromodulation therapies within 1 month before enrollment.
- Any other conditions that may affect safety, adherence or primary outcome evaluation at the discretion of investigators.
- Meet the diagnostic criteria for insomnia disorder, with insomnia symptoms persisting for ≥ 3 months and a total ISI score ≥ 15;
- For participants taking antidepressants, anxiolytics, antipsychotics, sedative-hypnotics or other medications that may affect sleep or mood, the dosage must have been relatively stable for 4 weeks prior to enrollment, and no proactive dose adjustment will be performed during the study period;
- Voluntarily participate in this study and provide written informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Cong Wang contact
About this study
Official title: Randomized Controlled Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Insomnia During the Withdrawal-Rehabilitation Period of Methamphetamine Use Disorder
The Department of Acupuncture-Moxibustion, the First Affiliated Hospital of Zhejiang Chinese Medical University is conducting a clinical research project entitled "Randomized Controlled Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation (transcutaneous auricular vagus nerve stimulation，taVNS) for Insomnia During the Withdrawal-Rehabilitation Period of Methamphetamine Use Disorder". This study aims to explore the short-term clinical efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS), based on the theory of "Heart-Kidney Interplay", in improving insomnia among patients with methamphetamine use disorder in the withdrawal-rehabilitation period on the basis of routine drug-addiction rehabilitation. The primary efficacy outcome is the change in total score of the Insomnia Severity Index (Insomnia Severity Index,ISI) from baseline to Week 4. This project will commence in September 2026, and a total of 96 participants with methamphetamine use disorder in the withdrawal-rehabilitation period will be recruited.
- Conditions
- Insomnia
- Being tested
- taVNS, sham-taVNS
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNSDevice
Stimulation targets: Bilateral auricles were stimulated simultaneously, targeting the bilateral cavum conchae (corresponding to the auricular acupoint "Heart" in traditional Chinese medicine) and cymba conchae (corresponding to the auricular acupoint "Kidney" in traditional Chinese medicine).
Stimulation parameters: Frequency: 4/20 Hz dense-sparse wave (alternation of 4 Hz for 5 seconds and 20 Hz for 10 seconds). Pulse width: 0.2 ms ± 30%. Intensity: individually adjusted. At the beginning of each treatment, the current intensity was slowly increased from 0 mA until the participant reported distinct pricking or tingling sensation without pain (0.8-1.5 mA).
Treatments were administered twice daily, 30 minutes per session. Treatment was performed 5 consecutive days per week (Monday to Friday), with 2-day rest intervals. The total intervention period was 4 weeks.
sham-taVNSDevice
Stimulating device and appearance: The identical stimulating device and electrodes as those used in the taVNS treatment group were adopted, with exactly the same operating procedures and treatment duration.
Stimulation target: The central area of bilateral earlobes. This region is considered to have extremely sparse vagus nerve innervation, and the physiological effects induced by stimulation at this site are negligible.
Stimulation parameters: The same device and parameter settings were applied as in the treatment group, while the current intensity was limited to within 0.1 mA. This design aims to make participants unable to distinguish between real and sham stimulation by sensory perception.
Treatment regimen: Treatments were delivered twice daily, 30 minutes per session. Treatment was performed for 5 consecutive days each week (Monday to Friday), followed by 2-day rest. The total intervention period was 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| taVNS treatment group | Experimental | Not described Receives: Device: taVNS |
| Sham-taVNS control group | Sham comparator | Not described Receives: Device: sham-taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.
Measured: Day 0 ，Week 1 ，Week 2 ，Week 3，Week 4
Secondary outcomes (17)
Pittsburgh Sleep Quality Index
Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). Total score ranges from 0 to 21; higher scores indicate poorer sleep quality.
Measured: Day 0 ，Week 1 ，Week 2 ，Week 3，Week 4
Sleep Diary
Bedtime, sleep onset latency, number and duration of nocturnal awakenings, early morning awakening, total sleep time, sleep efficiency, and morning mental status were recorded.
Measured: Day 0 ，Week 1 ，Week 2
17-item Hamilton Depression Rating Scale
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a clinician-rated scale for assessing the severity of depressive symptoms. It contains 17 items, with a total score ranging from 0 to 52. Higher scores indicate more severe depressive symptoms.
Measured: Day 0, Week 4, Week 8
Hamilton Anxiety Scale
The Hamilton Anxiety Scale (HAMA) is a 14-item clinician-rated scale to assess the severity of anxiety symptoms. Each item is scored from 0 to 4. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety symptoms.
Measured: Day 0, Week 4, Week 8
Fatigue Severity Scale
The Fatigue Severity Scale (FSS) is a 9-item self-reported questionnaire for assessing fatigue severity. Each item is scored on a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree). The total score ranges from 9 to 63, with higher scores indicating more severe fatigue.
Measured: Day 0, Week 4, Week 8
Epworth Sleepiness Scale
The Epworth Sleepiness Scale (ESS) is an 8-item self-reported questionnaire to assess the degree of daytime sleepiness. Each item is scored from 0 to 3. The total score ranges from 0 to 24, with higher scores indicating more severe daytime sleepiness.
Measured: Day 0, Week 4, Week 8
Drug Craving Visual Analogue Scale
Drug craving was assessed using the Visual Analogue Scale (VAS). The scale is a single-item self-reported measure for evaluating the intensity of drug craving. Scores range from 0 to 100 (or 0-10), with higher scores indicating stronger drug craving.
Measured: Day 0, Week 4, Week 8
Brief Substance Craving Scale
Brief Substance Craving Scale (BSCS). Score range: 0-12. Higher scores indicate greater substance craving (worse outcome).
Measured: Day 0, Week 4, Week 8
Chinese Version of the Stimulant Relapse Risk Scale
Chinese Version of the Stimulant Relapse Risk Scale (SRRS-C). Score range: 18-72. Higher scores indicate higher stimulant relapse risk (worse outcome).
Measured: Day 0, Week 4, Week 8
Heart Rate Variability
Heart rate variability (HRV) was recorded to assess autonomic nervous system function. Time-domain and frequency-domain parameters were extracted, including SDNN, RMSSD, LF, HF and LF/HF ratio. Higher HRV values indicate better vagal modulation and autonomic flexibility.
Measured: Day 0 ，Week 2
sleep efficiency
The proportion of time in bed actually spent asleep, usually calculated as Total Sleep Time divided by Time in Bed, multiplied by 100%.
Measured: Day 0 ，Week 1，Week 2
total sleep time
The total duration (in minutes) scored as sleep by the device or algorithm during the primary sleep period.
Measured: Day 0 ，Week 1，Week 2
sleep onset latency
The duration from sleep preparation (such as getting into bed and turning off the lights) to sleep onset.
Measured: Day 0 ，Week 1，Week 2
sleep onset latency after awakening
The total minutes classified as wakefulness between the time of falling asleep and the final awakening.
Measured: Day 0 ，Week 1，Week 2
Sleep Period
The total time interval between sleep onset and the final wake-up time (sleep offset).
Measured: Day 0 ，Week 1，Week 2
Night Waking Frequency
Number of night awakenings during sleep period. Unit: count. Higher values indicate worse sleep.
Measured: Day 0 ，Week 1，Week 2
Night Waking Duration
Total duration of night awakenings during sleep period. Unit: minutes. Higher values indicate worse sleep.
Measured: Day 0 ，Week 1，Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899957
- Sponsor's protocol ID
- 2026-KLS-389-01
- Status last verified
- Aug 2026
- First submitted
- 8 Sep 2026
- Last updated
- 28 Oct 2026
- Results posted
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Insomnia During the Withdrawal-Rehabilitation Period of Methamphetamine Use Disorder
- ClinicalTrials.gov ID
- NCT07899957
- Acronym / sponsor ID
- 2026-KLS-389-01
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 28 Oct 2026 (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.
The Department of Acupuncture-Moxibustion, the First Affiliated Hospital of Zhejiang Chinese Medical University is conducting a clinical research project entitled "Randomized Controlled Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation (transcutaneous auricular vagus nerve stimulation，taVNS) for Insomnia During the Withdrawal-Rehabilitation Period of Methamphetamine Use Disorder". This study aims to explore the short-term clinical efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS), based on the theory of "Heart-Kidney Interplay", in improving insomnia among patients with methamphetamine use disorder in the withdrawal-rehabilitation period on the basis of routine drug-addiction rehabilitation. The primary efficacy outcome is the change in total score of the Insomnia Severity Index (Insomnia Severity Index,ISI) from baseline to Week 4. This project will commence in September 2026, and a total of 96 participants with methamphetamine use disorder in the withdrawal-rehabilitation period will be recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taVNS treatment group | Experimental | Device: taVNS |
| Sham-taVNS control group | Sham comparator | Device: sham-taVNS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18-65 years, with no gender restriction.
- Meet the diagnostic criteria for amphetamine-type stimulant use disorder as defined by the *Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision* (DSM-5-TR).
- Methamphetamine is confirmed as the sole primary substance of use based on rehabilitation records, clinical history interviews and laboratory test data.
- Participants are in the abstinence rehabilitation phase. The interval since last methamphetamine use is ≥ 2 weeks, or acute intoxication and acute withdrawal reactions are judged to be substantially stable by investigators. No severe acute intoxication, delirium, or physically/psychiatrically unstable status requiring urgent management occurs within the preceding 2 weeks.
- Meet the diagnostic criteria for insomnia disorder, with insomnia symptoms lasting ≥ 3 months and a total Insomnia Severity Index (ISI) score ≥15.
Key exclusion criteria (14 listed)
- The primary substance of use is not methamphetamine, or there exists comorbid use disorders for opioids, ketamine, etomidate, dextromethorphan, alcohol or other major psychoactive substances that, in the investigators' judgment, may substantially confound assessments of sleep, mood, craving or heart rate variability (HRV).
- Presence of ongoing acute intoxication, severe acute withdrawal, delirium, or physically/psychiatrically unstable status requiring priority clinical management.
- Current severe depression with clear suicidal ideation or plans, urgent clinical risk indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS), or recent severe self-harm or suicidal behavior.
- Acute episode of psychotic disorders, manic/mixed episodes of bipolar disorder, severe cognitive impairment, or inability to complete study assessments.
- Suspected or confirmed other sleep disorders (including obstructive sleep apnea, narcolepsy, restless legs syndrome, circadian rhythm sleep-wake disorders and parasomnias) that can explain the main insomnia symptoms, as determined by investigators.
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 |
|---|---|---|
| taVNSStimulation targets: Bilateral auricles were stimulated simultaneously, targeting the bilateral cavum conchae (corresponding to the auricular acupoint "Heart" in traditional Chinese medicine) and cymba conchae (corresponding to the auricular acupoint "Kidney" in traditional Chinese medicine). Stimulation parameters: Frequency: 4/20 Hz dense-sparse wave (alternation of 4 Hz for 5 seconds and 20 Hz for 10 seconds). Pulse width: 0.2 ms ± 30%. Intensity: individually adjusted. At the beginning of each treatment, the current intensity was slowly increased from 0 mA until the participant reported distinct pricking or tingling sensation without pain (0.8-1.5 mA). Treatments were administered twice daily, 30 minutes per session. Treatment was performed 5 consecutive days per week (Monday to Friday), with 2-day rest intervals. The total intervention period was 4 weeks. | Device | taVNS treatment group |
| sham-taVNSStimulating device and appearance: The identical stimulating device and electrodes as those used in the taVNS treatment group were adopted, with exactly the same operating procedures and treatment duration. Stimulation target: The central area of bilateral earlobes. This region is considered to have extremely sparse vagus nerve innervation, and the physiological effects induced by stimulation at this site are negligible. Stimulation parameters: The same device and parameter settings were applied as in the treatment group, while the current intensity was limited to within 0.1 mA. This design aims to make participants unable to distinguish between real and sham stimulation by sensory perception. Treatment regimen: Treatments were delivered twice daily, 30 minutes per session. Treatment was performed for 5 consecutive days each week (Monday to Friday), followed by 2-day rest. The total intervention period was 4 weeks. | Device | Sham-taVNS control group |
Primary outcome
Insomnia Severity Index
Time frame: Day 0 ，Week 1 ，Week 2 ，Week 3，Week 4
Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.
17 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: Day 0 ，Week 1 ，Week 2 ，Week 3，Week 4
Sleep Diary
Time frame: Day 0 ，Week 1 ，Week 2
17-item Hamilton Depression Rating Scale
Time frame: Day 0, Week 4, Week 8
Hamilton Anxiety Scale
Time frame: Day 0, Week 4, Week 8
Fatigue Severity Scale
Time frame: Day 0, Week 4, Week 8
Epworth Sleepiness Scale
Time frame: Day 0, Week 4, Week 8
Drug Craving Visual Analogue Scale
Time frame: Day 0, Week 4, Week 8
Brief Substance Craving Scale
Time frame: Day 0, Week 4, Week 8
Chinese Version of the Stimulant Relapse Risk Scale
Time frame: Day 0, Week 4, Week 8
Heart Rate Variability
Time frame: Day 0 ，Week 2
sleep efficiency
Time frame: Day 0 ，Week 1，Week 2
total sleep time
Time frame: Day 0 ，Week 1，Week 2
sleep onset latency
Time frame: Day 0 ，Week 1，Week 2
sleep onset latency after awakening
Time frame: Day 0 ，Week 1，Week 2
Sleep Period
Time frame: Day 0 ，Week 1，Week 2
Night Waking Frequency
Time frame: Day 0 ，Week 1，Week 2
Night Waking Duration
Time frame: Day 0 ，Week 1，Week 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- 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.
Cong Wang contact
Questions about this trial
What is this clinical trial studying?
A study testing taVNS in people with Insomnia, run by The First Affiliated Hospital of Zhejiang Chinese Medical University.
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 7 inclusion and 14 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: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cong Wang, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: Day 0 ，Week 1 ，Week 2 ，Week 3，Week 4). 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 28 Oct 2026.