N/A
N=40
tAVNS for Stress Reduction in University Students
Psychological Distress · Stress (Psychology) · Perceived Stress
Bottom Line
View on ClinicalTrials.gov: NCT07411846 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Psychological Distress (K10) — 30.30; 29.5; 27.20; 27.10 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- taVNS (Device); Sham (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Psychological Distress (K10) |
30.30; 29.5; 27.20; 27.10; 24.15; 23.40 | — |
| PRIMARY Perceived Stress (PSS-10) |
24.05; 23.60; 21.85; 21.35; 19.40; 18.95 | — |
| PRIMARY Feasibility (Retention Rate) |
20; 20 | — |
| PRIMARY Tolerability (Adverse Events / Dropout Due to AEs) |
0; 0 | — |
Summary
The goal of this clinical trial is to learn if transcutaneous auricular vagus nerve stimulation (taVNS) works to reduce perceived stress and psychological distress in university students with high distress levels. The main questions it aims to answer are:
* Does taVNS reduce perceived stress (measured by PSS-10) in university students with high psychological distress?
* Does taVNS reduce psychological distress (measured by K10) in university students with high psychological distress?
* Is the intervention feasible and tolerable for implementation in higher-education mental health support?
Researchers will compare taVNS (electrode placed on the left tragus) to a sham stimulation group (electrode placed on the left earlobe) to see if taVNS reduces stress and distress.
Participants will:
* Attend five consecutive daily 30-minute stimulation sessions
* Complete stress and distress questionnaires before the intervention, immediately after, and at 1-month follow-up
* Receive electrical stimulation at individually adjusted intensity using the Nurosym device (pulse width 250 µs, frequency 20 Hz).
Eligibility Criteria
Inclusion Criteria
- Being a university student
- Age ≥18 years
- High to very high levels of psychological distress (K10 score ≥22)
Exclusion Criteria
- Psychotropic medication initiation or dose change within the last 3 months
- Substance dependence
- Current psychological or psychotherapeutic treatment
- Any formal mental disorder diagnosis
- Pregnancy
- History of dizziness or seizures
- Cochlear implants
- Ear plastic surgery
- Auricular malformations
Data sourced from ClinicalTrials.gov (NCT07411846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.