A Study of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Insomnia During Pregnancy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Xian
-
Shanxi, Xian, China, 710032
- Xijing Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Females aged 18-35 years, gestational age 20-34 weeks. Stable physical condition confirmed by routine laboratory tests (complete blood count, liver function, renal function, thyroid-stimulating hormone), urine toxicology screening, and electrocardiogram (ECG) at screening.
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:
- History of psychiatric disorders prior to pregnancy. History of psychoactive substance abuse. Prior exposure to taVNS (transcutaneous auricular vagus nerve stimulation) treatment.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Early intervention group: active taVNS first, then sham stimulation (crossover at Day 15)
|
The taVNS parameters were set at a pulse width of 200 μs and a frequency of 30 Hz.
|
|
Experimental: Early intervention group: sham stimulation first, then active taVNS (crossover at Day 15)
|
The taVNS parameters were set at a pulse width of 200 μs and a frequency of 30 Hz.
|
|
Experimental: Late intervention group: 2-week waiting period first, followed by 2 weeks of active taVNS
|
The taVNS parameters were set at a pulse width of 200 μs and a frequency of 30 Hz.
|
|
Sham Comparator: Late intervention group: 2-week waiting period first, followed by 2 weeks of sham taVNS
|
The taVNS parameters were set at a pulse width of 200 μs and a frequency of 10 Hz.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Insomnia Severity Index (ISI)
Time Frame: Change from baseline in Insomnia Severity Index (ISI) at week 2 and week 4
|
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.
|
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.
|
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) at week 2 and week 4.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hamilton Anxiety Rating Scale (HAMA)
Time Frame: Change from baseline in Hamilton Anxiety Rating Scale (HAMA) at week 2 and week 4.
|
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.
|
Change from baseline in Hamilton Depression Rating Scale (HAMD) at week 2 and week 4.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20242114-F-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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