NCT06682689 Investigation of TVNS Administration on Postpartum Mental Health
| NCT ID | NCT06682689 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Tuebingen |
| Condition | Postpartum Depression (PPD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-11 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-11 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Birgit Derntl, Prof., PhD
PRINCIPAL INVESTIGATOR
University Hospital Tübingen
Frequently Asked Questions
Who can join the NCT06682689 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Postpartum Depression (PPD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06682689 currently recruiting?
Yes, NCT06682689 is actively recruiting participants. Contact the research team at julia.siodmiak@med.uni-tuebingen.de for enrollment information.
Where is the NCT06682689 trial being conducted?
This trial is being conducted at Tübingen, Germany.
Who is sponsoring the NCT06682689 clinical trial?
NCT06682689 is sponsored by University Hospital Tuebingen. The principal investigator is Birgit Derntl, Prof., PhD at University Hospital Tübingen. The trial plans to enroll 120 participants.
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