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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Germany
University Hospital Tuebingen; Department of Psychiatry and Psychotherapy
RECRUITING
Tübingen
Contact Information
Primary
Julia Siodmiak, M.sc.
julia.siodmiak@med.uni-tuebingen.de
+49 (0)7071 29-85736
Time Frame
Start Date: 2024-11
Estimated Completion Date: 2026-12
Participants
Target number of participants: 120
Treatments
Experimental: 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.
Active_comparator: 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.
No_intervention: No tVNS
This group of participants will be included in all measurements (T1-T3) and check-ups, except for the tVNS stimulation.
Related Therapeutic Areas
Sponsors
Leads: University Hospital Tuebingen
Collaborators: German Center for Mental Health (DZPG)

This content was sourced from clinicaltrials.gov