An interventional study of transcutaneous auricular vagus nerve stimulation and sham taVNS stimulation in Insomnia, sponsored by Xijing Hospital. Active, not recruiting at 1 site in China. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Xijing Hospital · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn whether transcutaneous auricular vagus nerve stimulation (taVNS) can treat insomnia during pregnancy. It will also learn about the safety of taVNS for pregnant women and their fetuses. The main questions it aims to answer include:
Can taVNS improve sleep quality in patients with gestational insomnia, as measured primarily by the Insomnia Severity Index (ISI)? Compared with a 2-week delayed intervention, can starting taVNS intervention 2 weeks earlier lead to superior improvements in sleep and mood outcomes? Does taVNS have any adverse effects on maternal electrocardiogram, fetal ultrasound, or fetal heart rate? What medical problems (adverse events) do participants experience when receiving taVNS treatment? Researchers will compare active taVNS with sham stimulation (the device looks and operates the same but delivers no effective current), while also incorporating a delayed-intervention group (no intervention during the first 2 weeks) as a temporal control, to observe whether taVNS can treat gestational insomnia and whether earlier intervention offers additional advantages.
Participants will:
Receive active taVNS or sham stimulation according to their randomized group assignment during specified time periods, at a frequency of 2-3 times daily, 30 minutes per session, for 14 consecutive days (the early-intervention group begins immediately upon enrollment; the late-intervention group has a 2-week waiting period after enrollment before starting intervention; the early-intervention group undergoes crossover at Day 15).
Complete a 3-day pre-trial period after enrollment for device operation training and individualized stimulation intensity setting.
Attend hospital follow-up visits at baseline (Day 0), Day 15, and Day 30 to complete sleep assessments (ISI, AIS, PSQI, ESS) and mood assessments (HAMA, HAMD).
Undergo repeated maternal electrocardiogram, fetal ultrasound, and fetal heart rate monitoring before and after treatment to evaluate safety.
Maintain a daily treatment diary (recording usage time, frequency, and any adverse symptoms), with device-internal usage logs cross-checked against diaries to ensure adherence.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's planned enrollment of 200 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Fetal ultrasound and fetal heart rate monitoring performed and assessed by an obstetrician-gynecologist prior to enrollment.
Insomnia symptoms meeting all of the following criteria:
At least one of: (a) sleep onset latency > 30 minutes; (b) nocturnal awakenings ≥ 2 times/night; (c) total sleep time \< 6 hours; (d) accompanied by daytime dysfunction.
Symptoms occur despite adequate opportunity and appropriate circumstances for sleep.
At least one sleep-related daytime impairment: fatigue/malaise; impaired attention/memory; decreased academic/occupational/social functioning; mood disturbances/irritability; daytime sleepiness; reduced interest/energy; increased errors during work or driving; tension/headache/dizziness or other somatic symptoms related to sleep deficiency.
Symptoms persisted for ≥ 2 weeks. Confirmed eligible for enrollment by both an obstetrician and a neurologist. Willing and able to provide signed informed consent.
Exclusion Criteria:
Cardiac arrhythmia, particularly bradycardia. Currently receiving hypnotic medications or other insomnia treatments. Known fetal abnormalities (e.g., intrauterine growth restriction, congenital malformations, or cardiac rhythm abnormalities detected on fetal ultrasound).
History of adverse pregnancy outcomes or current pregnancy with known obstetric complications (e.g., gestational hypertension, gestational diabetes, or abnormal prenatal examination results).
Deemed unsuitable for enrollment following assessment by either the obstetrician or neurologist.
Device: transcutaneous auricular vagus nerve stimulation
Device: transcutaneous auricular vagus nerve stimulation
Device: transcutaneous auricular vagus nerve stimulation
Device: sham taVNS stimulation
The taVNS parameters were set at a pulse width of 200 μs and a frequency of 30 Hz.
The taVNS parameters were set at a pulse width of 200 μs and a frequency of 10 Hz.
Insomnia Severity Index (ISI)
Time frame: Change from baseline in Insomnia Severity Index (ISI) at week 2 and week 4
Epworth Sleepiness Scale (ESS)
Time frame: Change from baseline in Epworth Sleepiness Scale (ESS)at week 2 and week 4.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline in Pittsburgh Sleep Quality Index (PSQI) at week 2 and week 4.
Hamilton Anxiety Rating Scale (HAMA)
Time frame: Change from baseline in Hamilton Anxiety Rating Scale (HAMA) at week 2 and week 4.
Hamilton Depression Rating Scale (HAMD)
Time frame: Change from baseline in Hamilton Depression Rating Scale (HAMD) at week 2 and week 4.
Plan to share: Yes — all collected IPD
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Xijing Hospital