An interventional study of taVNS and sham-taVNS in Insomnia, sponsored by The First Affiliated Hospital of Zhejiang Chinese Medical University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by The First Affiliated Hospital of Zhejiang Chinese Medical University · Not applicable, Interventional, and Treatment
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.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's planned enrollment of 96 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →The First Affiliated Hospital of Zhejiang Chinese Medical University is the lead sponsor of 40 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: taVNS
Device: sham-taVNS
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.
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.
Insomnia Severity Index
Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.
Time frame: Day 0 ，Week 1 ，Week 2 ，Week 3，Week 4
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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%.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0 ，Week 1，Week 2
Sleep Period
The total time interval between sleep onset and the final wake-up time (sleep offset).
Time frame: Day 0 ，Week 1，Week 2
Night Waking Frequency
Number of night awakenings during sleep period. Unit: count. Higher values indicate worse sleep.
Time frame: Day 0 ，Week 1，Week 2
Night Waking Duration
Total duration of night awakenings during sleep period. Unit: minutes. Higher values indicate worse sleep.
Time frame: Day 0 ，Week 1，Week 2
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Feb 2028, 16 months later.
Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 16 months is close to that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders →
The First Affiliated Hospital of Zhejiang Chinese Medical University