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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Xian
-
Shanxi、Xian、中国、710032
- Xijing Hospital
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Early intervention group: active taVNS first, then sham stimulation (crossover at Day 15)
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The taVNS parameters were set at a pulse width of 200 μs and a frequency of 30 Hz.
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实验性的：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.
|
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实验性的：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.
|
|
假比较器：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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Insomnia Severity Index (ISI)
大体时间：Change from baseline in Insomnia Severity Index (ISI) at week 2 and week 4
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Change from baseline in Insomnia Severity Index (ISI) at week 2 and week 4
|
|
Epworth Sleepiness Scale (ESS)
大体时间：Change from baseline in Epworth Sleepiness Scale (ESS)at week 2 and week 4.
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Change from baseline in Epworth Sleepiness Scale (ESS)at week 2 and week 4.
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Pittsburgh Sleep Quality Index (PSQI)
大体时间：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.
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Hamilton Anxiety Rating Scale (HAMA)
大体时间：Change from baseline in Hamilton Anxiety Rating Scale (HAMA) at week 2 and week 4.
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Change from baseline in Hamilton Anxiety Rating Scale (HAMA) at week 2 and week 4.
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Hamilton Depression Rating Scale (HAMD)
大体时间：Change from baseline in Hamilton Depression Rating Scale (HAMD) at week 2 and week 4.
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Change from baseline in Hamilton Depression Rating Scale (HAMD) at week 2 and week 4.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- KY20242114-F-1
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
IPD 共享时间框架
IPD 共享支持信息类型
- 研究方案
- 树液
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