A Study of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Insomnia During Pregnancy

NCT07730762 | Active Not Recruiting DMC

• 1 other identifier: KY20242114-F-1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia

Keywords

Pregnant participants; Insomnia; transcutaneous auricular vagus nerve stimulation

Outcome Measures

Primary Outcomes (3)

• Insomnia Severity Index (ISI)

  Change from baseline in Insomnia Severity Index (ISI) at week 2 and week 4

• Epworth Sleepiness Scale (ESS)

  Change from baseline in Epworth Sleepiness Scale (ESS)at week 2 and week 4.

• Pittsburgh Sleep Quality Index (PSQI)

  Change from baseline in Pittsburgh Sleep Quality Index (PSQI) at week 2 and week 4.

Secondary Outcomes (2)

• Hamilton Anxiety Rating Scale (HAMA)

  Change from baseline in Hamilton Anxiety Rating Scale (HAMA) at week 2 and week 4.

• Hamilton Depression Rating Scale (HAMD)

  Change from baseline in Hamilton Depression Rating Scale (HAMD) at week 2 and week 4.

Study Arms (4)

Early intervention group: active taVNS first, then sham stimulation (crossover at Day 15)

EXPERIMENTAL

Device: transcutaneous auricular vagus nerve stimulation

Early intervention group: sham stimulation first, then active taVNS (crossover at Day 15)

EXPERIMENTAL

Device: transcutaneous auricular vagus nerve stimulation

Late intervention group: 2-week waiting period first, followed by 2 weeks of active taVNS

EXPERIMENTAL

Device: transcutaneous auricular vagus nerve stimulation

Late intervention group: 2-week waiting period first, followed by 2 weeks of sham taVNS

SHAM COMPARATOR

Device: sham taVNS stimulation

Interventions

transcutaneous auricular vagus nerve stimulation DEVICE

The taVNS parameters were set at a pulse width of 200 μs and a frequency of 30 Hz.

Early intervention group: active taVNS first, then sham stimulation (crossover at Day 15); Early intervention group: sham stimulation first, then active taVNS (crossover at Day 15); Late intervention group: 2-week waiting period first, followed by 2 weeks of active taVNS

sham taVNS stimulation DEVICE

The taVNS parameters were set at a pulse width of 200 μs and a frequency of 10 Hz.

Late intervention group: 2-week waiting period first, followed by 2 weeks of sham taVNS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Shanxi, Xian, 710032, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: August 30, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: starting 6 months after publication

Locations

CN (1)