Trial Outcomes & Findings for tAVNS for Stress Reduction in University Students (NCT NCT07411846)
NCT ID: NCT07411846
Last Updated: 2026-04-08
Results Overview
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.
COMPLETED
NA
40 participants
Baseline (pre-intervention), immediately post-intervention (after 5 daily sessions, approximately day 5), and 1-month follow-up
2026-04-08
Participant Flow
Participants were recruited from the Egas Moniz School of Health and Science (Almada, Portugal) via brief in-person classroom information sessions, after which interested students accessed an online enrollment link. Recruitment targeted university students with elevated psychological distress (K-10 ≥ 22).
Following online enrollment and completion of baseline assessment (sociodemographic questionnaire, PSS-10, and K-10), eligible participants were contacted by email to schedule sessions. Immediately before the first session, exclusion criteria were re-checked; no participant met exclusion criteria at that time. Randomization was performed using an online research randomizer (randomizer.org) in a 1:1 ratio after eligibility confirmation.
Participant milestones
| Measure |
taVNS
Participants receive five consecutive daily 30-minute sessions of transcutaneous auricular vagus nerve stimulation using the Nurosym device. The electrode is positioned on the left tragus. Participants received only active taVNS during the randomized phase; no cross-over to other interventions occurred during the trial.
|
Sham
Participants received only sham stimulation during the randomized phase. No cross-over occurred and all analyses reflect the original randomized groups.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
taVNS
n=20 Participants
Participants receive five consecutive daily 30-minute sessions of transcutaneous auricular vagus nerve stimulation using the Nurosym device. The electrode is positioned on the left tragus.
|
Sham
n=20 Participants
Participants receive five consecutive daily 30-minute sessions of transcutaneous auricular vagus nerve stimulation using the Nurosym device. The electrode is positioned on the left earlobe
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.95 Years
STANDARD_DEVIATION 2.48 • n=20 Participants
|
21.35 Years
STANDARD_DEVIATION 3.03 • n=20 Participants
|
21.15 Years
STANDARD_DEVIATION 2.74 • n=40 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
33 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Psychological Distress at Baseline (K-10)
|
30.30 Scores on a scale
STANDARD_DEVIATION 4.60 • n=20 Participants
|
29.50 Scores on a scale
STANDARD_DEVIATION 6.29 • n=20 Participants
|
29.90 Scores on a scale
STANDARD_DEVIATION 5.45 • n=40 Participants
|
|
Perceived Stress at Baseline (PSS-10)
|
24.05 Scores on a scale
STANDARD_DEVIATION 3.82 • n=20 Participants
|
23.60 Scores on a scale
STANDARD_DEVIATION 4.98 • n=20 Participants
|
23.83 Scores on a scale
STANDARD_DEVIATION 4.4 • n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-intervention), immediately post-intervention (after 5 daily sessions, approximately day 5), and 1-month follow-upPsychological 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.
Outcome measures
| Measure |
taVNS
n=20 Participants
Participants receive five consecutive daily 30-minute sessions of transcutaneous auricular vagus nerve stimulation using the Nurosym device. The electrode is positioned on the left tragus.
|
Sham
n=20 Participants
Participants receive five consecutive daily 30-minute sessions of transcutaneous auricular vagus nerve stimulation using the Nurosym device. The electrode is positioned on the left earlobe
|
|---|---|---|
|
Psychological Distress (K10)
Baseline
|
30.30 Scores on a scale
Standard Deviation 4.60
|
29.5 Scores on a scale
Standard Deviation 6.29
|
|
Psychological Distress (K10)
Post-intervention
|
27.20 Scores on a scale
Standard Deviation 6.97
|
27.10 Scores on a scale
Standard Deviation 5.61
|
|
Psychological Distress (K10)
Follow-up
|
24.15 Scores on a scale
Standard Deviation 6.82
|
23.40 Scores on a scale
Standard Deviation 6.59
|
PRIMARY outcome
Timeframe: Baseline (pre-intervention), immediately post-intervention (after 5 daily sessions, approximately day 5), and 1-month follow-upPerceived 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.
Outcome measures
| Measure |
taVNS
n=20 Participants
Participants receive five consecutive daily 30-minute sessions of transcutaneous auricular vagus nerve stimulation using the Nurosym device. The electrode is positioned on the left tragus.
|
Sham
n=20 Participants
Participants receive five consecutive daily 30-minute sessions of transcutaneous auricular vagus nerve stimulation using the Nurosym device. The electrode is positioned on the left earlobe
|
|---|---|---|
|
Perceived Stress (PSS-10)
Baseline
|
24.05 Scores on a scale
Standard Deviation 3.82
|
23.60 Scores on a scale
Standard Deviation 4.98
|
|
Perceived Stress (PSS-10)
Post-intervention
|
21.85 Scores on a scale
Standard Deviation 5.95
|
21.35 Scores on a scale
Standard Deviation 5.42
|
|
Perceived Stress (PSS-10)
Follow-up
|
19.40 Scores on a scale
Standard Deviation 6.69
|
18.95 Scores on a scale
Standard Deviation 6.25
|
PRIMARY outcome
Timeframe: From randomization through 1-month follow-upFeasibility 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.
Outcome measures
| Measure |
taVNS
n=20 Participants
Participants receive five consecutive daily 30-minute sessions of transcutaneous auricular vagus nerve stimulation using the Nurosym device. The electrode is positioned on the left tragus.
|
Sham
n=20 Participants
Participants receive five consecutive daily 30-minute sessions of transcutaneous auricular vagus nerve stimulation using the Nurosym device. The electrode is positioned on the left earlobe
|
|---|---|---|
|
Feasibility (Retention Rate)
|
20 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
taVNS
n=20 Participants
Participants receive five consecutive daily 30-minute sessions of transcutaneous auricular vagus nerve stimulation using the Nurosym device. The electrode is positioned on the left tragus.
|
Sham
n=20 Participants
Participants receive five consecutive daily 30-minute sessions of transcutaneous auricular vagus nerve stimulation using the Nurosym device. The electrode is positioned on the left earlobe
|
|---|---|---|
|
Tolerability (Adverse Events / Dropout Due to AEs)
|
0 Participants
|
0 Participants
|
Adverse Events
taVNS
Sham
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Paulo Chaló
Egas Moniz School of Health and Science
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place