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.
Aged 18 to 35 years.
Undergraduate student enrolled in a Health Sciences degree program.
Poor sleep quality defined as PSQI > 7.
Meets diagnostic criteria for primary insomnia according to ICSD-3.
Current severe psychiatric disorder or ongoing psychotherapy treatment.
Neurological disorders (e.g., epilepsy).
Cardiac arrhythmias or implanted cardiac devices (e.g., pacemaker).
Current use of medications that significantly affect sleep (e.g., hypnotics or anxiolytics), unless stable and approved by the investigator.
Parallel
Auricular Transcutaneous Vagus Nerve Stimulation (tVNS)
DeviceHome-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
DeviceControl 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.
Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)
PSQI total score (0-21). Higher scores indicate worse sleep quality.
Anxiety Symptoms (Beck Anxiety Inventory, BAI)
BAI total score. Higher scores indicate greater anxiety symptoms.
Insomnia Severity (Insomnia Severity Index, ISI)
ISI total score. Higher scores indicate greater insomnia severity.
Daytime Sleepiness (Epworth Sleepiness Scale, ESS)
ESS total score. Higher scores indicate greater daytime sleepiness.
Perceived Stress (Perceived Stress Scale-14, PSS-14)
PSS-14 total score. Higher scores indicate greater perceived stress.
Quality of Life (12-Item Short Form Survey, SF-12 v2)
SF-12 v2 component summary scores (physical and mental). Higher scores indicate better health-related quality of life.
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