NCT07411846: tAVNS4HES

tAVNS for Stress Reduction in University Students

Completed NA Results posted Last updated 8 April 2026

What this trial tests

NA trial testing taVNS in Psychological Distress in 40 participants. Completed in 10 June 2025.

Timeline

10 January 2025

Primary endpoint
17 March 2025

10 June 2025

Quick facts

Lead sponsor	Egas Moniz - Cooperativa de Ensino Superior, CRL
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	10 January 2025
Primary completion	17 March 2025
Estimated completion	10 June 2025
Sites	1 location across Portugal

Drugs / interventions tested

• taVNS
• Sham

Conditions studied

• Psychological Distress — all drugs for Psychological Distress →
• Stress (Psychology) — all drugs for Stress (Psychology) →
• Perceived Stress — all drugs for Perceived Stress →

Sponsor

Egas Moniz - Cooperativa de Ensino Superior, CRL — full company profile →

Who can join

18 and older, any sex, with Psychological Distress or Stress (Psychology). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Psychological Distress (K10) Primary · Baseline (pre-intervention), immediately post-intervention (after 5 daily sessions, approximately day 5), and 1-month follow-up

Psychological distress assessed using the 10-item Kessler Psychological Distress Scale (K10). Scored 1 ("never") to 5 ("always") with reference to the prior 30 days and summed to a total score of 10-50, with higher scores indicating higher distress.

Baseline

Group	Value	95% CI
taVNS	30.30	± 4.60
Sham	29.5	± 6.29

Post-intervention

Group	Value	95% CI
taVNS	27.20	± 6.97
Sham	27.10	± 5.61

Follow-up

Group	Value	95% CI
taVNS	24.15	± 6.82
Sham	23.40	± 6.59

Perceived Stress (PSS-10) Primary · Baseline (pre-intervention), immediately post-intervention (after 5 daily sessions, approximately day 5), and 1-month follow-up

Perceived stress assessed using the 10-item Perceived Stress Scale (PSS-10). Scored 0 ("never") to 4 ("very often") and summed to a total score of 0-40, with higher scores indicating higher perceived stress.

Baseline

Group	Value	95% CI
taVNS	24.05	± 3.82
Sham	23.60	± 4.98

Post-intervention

Group	Value	95% CI
taVNS	21.85	± 5.95
Sham	21.35	± 5.42

Follow-up

Group	Value	95% CI
taVNS	19.40	± 6.69
Sham	18.95	± 6.25

Feasibility (Retention Rate) Primary · From randomization through 1-month follow-up

Feasibility was assessed using retention of participants from baseline to the end of the study. For each arm, the number of randomized participants who completed all five stimulation sessions and the 1-month follow-up assessment was recorded.

Group	Value	95% CI
taVNS	20
Sham	20

Tolerability (Adverse Events / Dropout Due to AEs) Primary · From the first to the fifth stimulation session (Days 1-5), with adverse events assessed immediately before and after each intervention session.

Tolerability was assessed by monitoring adverse events before and after each session through visual inspection of the stimulation site and open-ended participant self-report questioning. The number of participants who discontinued participation due to any adverse event was recorded.

Group	Value	95% CI
taVNS	0
Sham	0

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.