Home-Based Auricular Transcutaneous Vagus Nerve Stimulation (tVNS) for Sleep Quality and Psycho-Academic Outcomes in Health Sciences Students

Sponsor
University of Malaga
Study ID
NCT07371715
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Auricular Transcutaneous Vagus Nerve Stimulation (tVNS) — DEVICE
    Home-based auricular transcutaneous vagus nerve stimulation (tVNS) delivered using a low-frequency TENS-like device. Stimulation is applied to the left cymba conchae (or tragus if needed) for 60 minutes per session, 5 sessions per week for 3 weeks. Biphasic symmetrical waveform (25 Hz, 200 μs pulse width). Intensity is individually adjusted to a strong but comfortable paresthesia below pain threshold.
  • Sham stimulation — DEVICE
    Control stimulation delivered using the same low-frequency TENS-like device and parameters (25 Hz, 200 μs) applied to the ipsilateral earlobe to mimic sensory stimulation. Sessions are performed for 60 minutes per session, 5 sessions per week for 3 weeks, without targeting auricular vagal afferents.

Study Details

This study aims to evaluate the efficacy, safety, and feasibility of a home-based auricular transcutaneous vagus nerve stimulation (tVNS) program in Health Sciences university students with poor sleep quality. Participants will be randomly assigned (1:1) to receive either active auricular stimulation (cymba conchae/tragus) or a control stimulation applied to the earlobe. The intervention will be self-administered at home using a low-frequency TENS-like device for 60 minutes per session, 5 sessions per week for 3 weeks. Sleep quality will be primarily assessed using the Pittsburgh Sleep Quality Index (PSQI) before and after the intervention. Secondary outcomes include insomnia severity, daytime sleepiness, perceived stress, anxiety, quality of life, and psycho-academic outcomes.

Key Dates

First listed
Jan 28, 2026
Start date
Mar 1, 2026
Status verified
Jan 2026
Primary completion
May 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active tVNS
    Home-based auricular transcutaneous vagus nerve stimulation (tVNS) applied to the left cymba conchae (or tragus if needed) using a low-frequency TENS-like device. Sessions are performed for 60 minutes, 5 days/week for 3 weeks. Stimulation intensity is adjusted to a strong but comfortable paresthesia below pain threshold.
  • Placebo Comparator: Control (Earlobe Stimulation)
    Control stimulation delivered to the ipsilateral earlobe using the same device and schedule as the active intervention (60 minutes, 5 days/week for 3 weeks) to mimic sensory stimulation without targeting auricular vagal afferents.

Primary Outcome Measure

Sleep Quality (Pittsburgh Sleep Quality Index, PSQI) [ Time Frame: Baseline and end of week 3 ]

Central Contacts

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