About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Auricular Transcutaneous Vagus Nerve Stimulation (tVNS)
- Sham stimulation