Actively Recruiting
Integrative Investigation of Transcutaneous Vagus Nerve Stimulation Impact on Postpartum Mental Health Through Wearable Technology, Hormonal Analysis, and Modulatory Factors
Led by University Hospital Tuebingen · Updated on 2024-11-12
120
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University Hospital Tuebingen
Lead Sponsor
G
German Center for Mental Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of transcutaneous vagus nerve stimulation (tVNS) on mood swings and depressive symptoms in women during the postpartum period. The study aims to determine if tVNS can help prevent mood changes and serve as an additional intervention for mood symptoms after childbirth. The investigation will focus on the first 12 weeks following delivery, examining various factors including physiological functions, stress, hormones, environment, and personality traits. The study uses a crossover design with three groups of women who have recently given birth. Two groups will receive different intensities of tVNS stimulation for six weeks each, switching protocols after this period. One group will have high-intensity stimulation, the other low-intensity, and a third group will receive no stimulation but will be monitored similarly. The tVNS device used is CE-certified and stimulates the vagus nerve non-invasively through the ear. Participants will be guided on device use and monitored using smartwatches, questionnaires, and hormone sampling. Participants will complete psychometric and neuropsychological tests at multiple time points, provide hair and blood samples for hormone analysis, and report daily mood and mental health through app-based assessments. Assessments will occur during pregnancy, and at 6 and 12 weeks postpartum, with a follow-up planned at 6 and 9 months postpartum. The study will measure changes in depression symptoms, mood, sleep quality, stress levels, heart rate variability, and daily activity, aiming to gather a comprehensive view of postpartum mental health and tVNS effects.
CONDITIONS
Brief Title
Investigation of TVNS Administration on Postpartum Mental Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- No malformation of fetal organs detected during organ screening
- Ability to provide written consent
- Sufficient German language skills to understand and communicate during the study
You will not qualify if you...
- Active implants such as cochlear implants or cardiac pacemakers
- Pregnancy
- Cerebral shunts or skin problems
- Cardiovascular health issues including cardiac arrhythmias and coronary heart disease
- Neurological disorders
- Current diagnosis or episode of a mood disorder
- Diagnosed schizophrenia spectrum or other psychotic disorders
- Severe substance use disorders
- Any health issue deemed by the study clinician to pose a disadvantage for the participant or child
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks before birth
Participants receive instructions on using the tVNS device and complete baseline assessments including questionnaires, neuropsychological tests, and hair sampling for cortisol analysis.
1 baseline visit (in-person)
Duration - 12 weeks postpartum
Participants in the two stimulation groups use the tVNS device daily with assigned intensity protocols for six weeks, then switch to the alternate protocol for another six weeks. The no stimulation group does not use the device but participates in all assessments. All participants complete daily mood reports and repeated questionnaires throughout this period.
Daily app-based mood assessments and 2 lab visits at weeks 6 and 12 postpartum
Duration - Up to 9 months postpartum
Participants are invited to complete voluntary online questionnaires assessing mental health, physical well-being, and parenting stress at 6 and 9 months postpartum.
2 online questionnaire sessions
Trial Site Locations
Total: 1 location
1
University Hospital Tuebingen; Department of Psychiatry and Psychotherapy
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
Research Team
J
Julia Siodmiak, M.sc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here