RecruitingNot ApplicableNCT06682689

Investigation of TVNS Administration on Postpartum Mental Health

Integrative Investigation of Transcutaneous Vagus Nerve Stimulation: Impact on Postpartum Mental Health Through Wearable Technology, Hormonal Analysis and Modulatory Factors

Sponsor

University Hospital Tuebingen

Enrollment

120 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Postpartum Anxiety Postpartum Depression (PPD)Postpartum Sadness Postpartum Blues

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a gentle, non-invasive nerve stimulation treatment applied to the ear (transcutaneous vagus nerve stimulation, or tVNS) can help prevent or reduce postpartum depression and anxiety in new mothers. **You may be eligible if...** - You have recently given birth and your baby had no organ abnormalities detected during pregnancy - You are able to give written consent for yourself - You have sufficient German language skills to understand the study procedures **You may NOT be eligible if...** - You have an active implant such as a cochlear implant or pacemaker - You have a history of heart arrhythmias, coronary disease, or neurological disorders - You currently have or have recently had a mood disorder, schizophrenia, or severe substance use disorder - You are still pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEtranscutaneous vagus nerve stimulation

Two groups will use a tVNS stimulator for 12 weeks. Group 1 will apply active stimulation for up to 4 hours daily at a comfortable level for 6 weeks, while Group 2 will use it at the lowest intensity (0.1 mA). After 6 weeks (T2), the groups will switch. Participants will be instructed to use the device for at least 1 hour a day, with a recommendation of 4 hours, following guidelines and recent studies. The CE-certified tVNS® E device non-invasively stimulates the vagus nerve via the ear. It is approved for treating a.o.depression. Device parameters (intensity, pulse length, frequency) mimic invasive VNS techniques, ensuring safe and effective signal transmission. Stimulation will be applied to the left ear, with intensity adjusted to a tingling sensation, avoiding discomfort. The study follows an approved protocol, with low-intensity stimulation as a control. The device delivers biphasic impulses at 25 Hz, with 28 seconds ON and 32 seconds OFF, and is safe for extended use.