tAVNS for Stress Reduction in University Students

NCT07411846 | Completed Results

• 1 other identifier: PT-280/24
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Psychological Distress; Stress (Psychology); Perceived Stress

Keywords

Transcutaneous auricular vagus nerve stimulation; taVNS; Perceived stress; Psychological distress; University students; Neuromodulation; Mental health; Student well-being

Outcome Measures

Primary Outcomes (4)

• Psychological Distress (K10)

  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 (pre-intervention), immediately post-intervention (after 5 daily sessions, approximately day 5), and 1-month follow-up

• Perceived Stress (PSS-10)

  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 (pre-intervention), immediately post-intervention (after 5 daily sessions, approximately day 5), and 1-month follow-up

• Feasibility (Retention Rate)

  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.

  From randomization through 1-month follow-up

• Tolerability (Adverse Events / Dropout Due to AEs)

  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.

  From the first to the fifth stimulation session (Days 1-5), with adverse events assessed immediately before and after each intervention session.

Study Arms (2)

taVNS - Tragus Stimulation (Initial Treatment Only)

EXPERIMENTAL

Participants received only active taVNS during the randomized phase; no cross-over to other interventions occurred during the trial.

Device: taVNS

Sham - Earlobe Stimulation (Initial Treatment Only)

SHAM COMPARATOR

Participants received only sham stimulation during the randomized phase. No cross-over procedures were included in the registered study design or analyses.

Device: Sham

Interventions

taVNS DEVICE

Non-invasive electrical stimulation delivered via the Nurosym device targeting the auricular branch of the vagus nerve. Electrode placement on the left tragus. Parameters: pulse width 250 µs, frequency 20 Hz, intensity individually adjusted to perception threshold. Five consecutive daily 30-minute sessions.

Also known as: Auricular vagus nerve stimulation, Tragus stimulation

taVNS - Tragus Stimulation (Initial Treatment Only)

Sham DEVICE

Non-invasive electrical stimulation delivered via the Nurosym device with electrode placement on the left earlobe. Identical parameters to active intervention (taVNS): pulse width 250 µs, frequency 20 Hz, intensity individually adjusted to perception threshold. Five consecutive daily 30-minute sessions.

Also known as: Earlobe stimulation

Sham - Earlobe Stimulation (Initial Treatment Only)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being a university student
• Age ≥18 years
• High to very high levels of psychological distress (K10 score ≥22)

You may not qualify if:

• 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

Sponsors & Collaborators

• Egas Moniz - Cooperativa de Ensino Superior, CRL: lead

Study Sites (1)

Egas Moniz School of Health & Science

Almada, Setúbal District, 2829 - 511, Portugal

Location

Related Publications (11)

• Badran BW, Dowdle LT, Mithoefer OJ, LaBate NT, Coatsworth J, Brown JC, DeVries WH, Austelle CW, McTeague LM, George MS. Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: A concurrent taVNS/fMRI study and review. Brain Stimul. 2018 May-Jun;11(3):492-500. doi: 10.1016/j.brs.2017.12.009. Epub 2017 Dec 29.

  PMID: 29361441 BACKGROUND

• Borges U, Pfannenstiel M, Tsukahara J, Laborde S, Klatt S, Raab M. Transcutaneous vagus nerve stimulation via tragus or cymba conchae: Are its psychophysiological effects dependent on the stimulation area? Int J Psychophysiol. 2021 Mar;161:64-75. doi: 10.1016/j.ijpsycho.2021.01.003. Epub 2021 Jan 11.

  PMID: 33444689 BACKGROUND

• Bremner JD, Gurel NZ, Wittbrodt MT, Shandhi MH, Rapaport MH, Nye JA, Pearce BD, Vaccarino V, Shah AJ, Park J, Bikson M, Inan OT. Application of Noninvasive Vagal Nerve Stimulation to Stress-Related Psychiatric Disorders. J Pers Med. 2020 Sep 9;10(3):119. doi: 10.3390/jpm10030119.

  PMID: 32916852 BACKGROUND

• Cuberos Paredes E, Goyes D, Mak S, Yardimian R, Ortiz N, McLaren A, Stauss HM. Transcutaneous auricular vagus nerve stimulation inhibits mental stress-induced cortisol release-Potential implications for inflammatory conditions. Physiol Rep. 2025 Feb;13(3):e70251. doi: 10.14814/phy2.70251.

  PMID: 39936474 BACKGROUND

• Deuchars SA, Lall VK, Clancy J, Mahadi M, Murray A, Peers L, Deuchars J. Mechanisms underpinning sympathetic nervous activity and its modulation using transcutaneous vagus nerve stimulation. Exp Physiol. 2018 Mar 1;103(3):326-331. doi: 10.1113/EP086433. Epub 2017 Dec 3.

  PMID: 29205954 BACKGROUND

• Dos Reis LD, Pereira Generoso L, Pereira GS, Teixeira Baru JPDS, Candido NL, Maziero Capello MG, de Castro ROM, Cardoso EJR, Scoz RD, Ferreira LMA, da Silva ML, da Silva JRT. Effects of multisession prefrontal cortex tDCS or taVNS on stress, perceived stress and sleep quality: a double-blind, randomized controlled study. Front Psychol. 2024 Sep 13;15:1343413. doi: 10.3389/fpsyg.2024.1343413. eCollection 2024.

  PMID: 39346507 BACKGROUND

• Ferreira LMA, Brites R, Fraiao G, Pereira G, Fernandes H, de Brito JAA, Pereira Generoso L, Maziero Capello MG, Pereira GS, Scoz RD, Silva JRT, Silva ML. Transcutaneous auricular vagus nerve stimulation modulates masseter muscle activity, pain perception, and anxiety levels in university students: a double-blind, randomized, controlled clinical trial. Front Integr Neurosci. 2024 Jul 10;18:1422312. doi: 10.3389/fnint.2024.1422312. eCollection 2024.

  PMID: 39051059 BACKGROUND

• Hernandez-Torrano D, Ibrayeva L, Sparks J, Lim N, Clementi A, Almukhambetova A, Nurtayev Y, Muratkyzy A. Mental Health and Well-Being of University Students: A Bibliometric Mapping of the Literature. Front Psychol. 2020 Jun 9;11:1226. doi: 10.3389/fpsyg.2020.01226. eCollection 2020.

  PMID: 32581976 BACKGROUND

• Karyotaki E, Cuijpers P, Albor Y, Alonso J, Auerbach RP, Bantjes J, Bruffaerts R, Ebert DD, Hasking P, Kiekens G, Lee S, McLafferty M, Mak A, Mortier P, Sampson NA, Stein DJ, Vilagut G, Kessler RC. Sources of Stress and Their Associations With Mental Disorders Among College Students: Results of the World Health Organization World Mental Health Surveys International College Student Initiative. Front Psychol. 2020 Jul 30;11:1759. doi: 10.3389/fpsyg.2020.01759. eCollection 2020.

  PMID: 32849042 BACKGROUND

• Kim AY, Marduy A, de Melo PS, Gianlorenco AC, Kim CK, Choi H, Song JJ, Fregni F. Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Sci Rep. 2022 Dec 21;12(1):22055. doi: 10.1038/s41598-022-25864-1.

  PMID: 36543841 BACKGROUND

• Mofatteh M. Risk factors associated with stress, anxiety, and depression among university undergraduate students. AIMS Public Health. 2020 Dec 25;8(1):36-65. doi: 10.3934/publichealth.2021004. eCollection 2021.

  PMID: 33575406 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Limitations and Caveats

Limitations include the small sample size (N = 40), reliance on self-reports (PSS-10, K-10), predominantly female sample (82.5%), and self-reported mental disorder exclusion. While the earlobe condition provided a credible sham, its potential physiological activity may have reduced sensitivity to detect site-specific effects.

Results Point of Contact

• Title: Paulo Chaló
• Organization: Egas Moniz School of Health and Science

pchalo@egasmoniz.edu.pt

(+351) 212 946 700

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a blinded clinical trial where participants are not informed of their group allocation (taVNS vs sham). Both groups undergo identical procedures with the same stimulation device, parameters, and session duration; the only difference is electrode placement (tragus vs earlobe). Outcomes are assessed via self-report questionnaires completed by participants who remain blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel assignment with blinded sham control. Participants are randomly allocated to receive either active transcutaneous auricular vagus nerve stimulation (taVNS) with electrode placement on the left tragus or sham stimulation with electrode placement on the left earlobe. Both groups receive identical stimulation parameters except for electrode location.

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: January 10, 2025
• Primary Completion: March 17, 2025
• Study Completion: June 10, 2025
• Last Updated: April 8, 2026
• Results First Posted: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)