Integrative Investigation of Transcutaneous Vagus Nerve Stimulation: Impact on Postpartum Mental Health Through Wearable Technology, Hormonal Analysis and Modulatory Factors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- tVNS-induced changes in postpartum depression symptoms
研究概览
简要总结
The aim of the study is to explore whether transcutaneous vagus nerve stimulation (tVNS) may be effective in preventing mood swings and depressive symptoms in the postpartum phase, as well as serving as a supplementary intervention in cases where mood symptoms develop. The study will investigate the effects of tVNS intervention during the first 12 weeks postpartum. Pregnant women will be recruited for the study, and the intervention will begin shortly after giving birth. Participants will receive different instructions on how to use the tVNS device. Additional parameters such as physiological functions, chronic stress, hormones, environment, and personality traits will also be assessed.
详细描述
The study uses a crossover, repeated-measures, within-subject, and between-subject placebo and active control design. Three groups of women who have recently given birth will receive either high-intensity tVNS, low-intensity tVNS, or no stimulation intervention for six weeks. After this period, the two tVNS groups will switch protocols for another six weeks. Participants will also undergo a battery of psychometric and neuropsychological tests at multiple time points. By applying a multilevel approach, the investigators will assess changes in postpartum mood and mental state from subjective (daily mood assessments, psychometric tests), cognitive (neuropsychological tests), physiological (heart rate, sleep patterns), and endocrine (cortisol, sex hormones) perspectives.
Throughout the study, all participants will answer app-based ecological momentary assessments (EMA) to monitor mood fluctuations after stimulation and compare outcomes. Participants' partners will be invited to take part in the study if they wish; they will complete questionnaires regarding their mental health and the perceived support they provide. During the initial screening, participants will receive detailed information about the study, and inclusion and exclusion criteria will be evaluated.
At the first meeting (T1), informed broad consent will be obtained, and the study will be explained in detail. Instructions for using the tVNS devices will be provided based on group assignments. Participants will complete questionnaires, undergo a short neuropsychological test, and provide hair samples for cortisol concentration analysis.
After giving birth, participants (or their partners, with permission) will notify the researchers, and each woman in the experimental tVNS groups will receive a package containing the stimulator and access to usage tutorials and instructions. All participants will also receive smartwatches with usage instructions.
The main study will include 120 women who have recently given birth, randomly assigned to one of three groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •No malformation of fetal organs (no abnormalities detected during "organ screening").
- •Ability to provide written consent for themselves.
- •Sufficient German language skills to communicate and understand study procedures.
排除标准
- •Exclusion criteria for tVNS use (i.e., pregnancy, active implants such as cochlear implants or cardiac pacemakers, cerebral shunts, skin problems, cardiovascular health issues).
- •Cardiac arrhythmias or coronary heart disease.
- •Neurological disorders.
- •Current diagnosis or episode of a mood disorder.
- •Diagnosed schizophrenia spectrum and other psychotic disorders.
- •Severe substance use disorders.
- •Individual exclusion may also occur based on other health issues if the study clinician determines that participation in the study may pose a disadvantage for the participant or the child.
研究组 & 干预措施
High-low tVNS
Participants in this group will be instructed to use the tVNS device every day for the first six weeks according to the manufacturer's guidelines, at an intensity where they can feel a tingling sensation but below the pain threshold. After six weeks (T2) of intervention, they will be asked to switch to a different protocol for the next six weeks, using the device at the lowest possible intensity. Additional instructions will be provided, and they will be informed that this stimulation uses different parameters set by the research team.
干预措施: transcutaneous vagus nerve stimulation (Device)
Low-high tVNS
Participants in this group will receive the inverted intervention, with the first six weeks of stimulation at the lowest possible intensity (0.1 mA) with the same instructions regarding duration of stimulations, followed by six weeks of high-intensity stimulation as instructed by the manufacturer.
干预措施: transcutaneous vagus nerve stimulation (Device)
No tVNS
This group of participants will be included in all measurements (T1-T3) and check-ups, except for the tVNS stimulation.
结局指标
主要结局
tVNS-induced changes in postpartum depression symptoms
时间窗: Measured during pregnancy (T1), 6 weeks after birth (T2), and 12 weeks after birth (T3)]
To evaluate the effect of transcutaneous vagus nerve stimulation (tVNS) on depressive symptoms, as measured by the Edinburgh Postpartum Depression Scale (EPDS), which ranges from 0 to 30, with higher scores indicating more severe depressive symptoms. A standard cut-off score of 12-13 is typically used to indicate probable depressive symptoms. The total EPDS score will be assessed at multiple time points throughout the study, allowing for the comparison of changes in depressive symptom trajectories across conditions (tVNS vs. control). This design aims to capture differences in the development and progression of depressive symptoms between groups over the course of pregnancy and postpartum.
tVNS-induced changes in the daily mood
时间窗: From the recruitment through first 12 weeks of postpartum period
The study will track and analyze the daily trajectory of mood changes-both positive and negative-from a baseline period prior to the 6-week transcutaneous vagus nerve stimulation (tVNS) intervention and throughout the intervention period, with assessments concluding on the final day of the intervention. Daily mood changes and stability will be measured using the Positive and Negative Affect Schedule (PANAS), administered through app-based ecological momentary assessment (EMA). Each item on the PANAS is rated on a 5-point Likert scale, ranging from 1 ("gar nichts" / "not at all") to 5 ("äußerst" / "extremely"), with higher scores reflecting a greater intensity of the specified mood. Positive affect (PA) scores represent more positive mood states (higher scores indicating better mood), while negative affect (NA) scores indicate the severity of negative mood states (higher scores representing worse mood). The analysis will focus on identifying trends, patterns, and fluctuations in mood
次要结局
- Heart-rate variability changes(From the recruitment through first 12 weeks of postpartum period)
- Subjective sleep quality changes(through study completion, an average of 6 months)
- Objective sleep quality(through study completion, an average of 6 months)
- Postpartum depression diagnosis (clinical threshold)(From the birth of the child to the end of the study (12 weeks))
- Intervention acceptance analysis(through study completion, an average of 6 months)
- Objective measure of chronic stress(Two measurements: During pregnancy (T1) and 12 weeks postpartum (T3))
- Subjective chronic stress levels(Three times: During 1st visit, at 6 weeks postpartum and 12 weeks after birth)
- Daily activity changes induced by tVNS(From the recruitment through first 12 weeks of postpartum period)