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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorUniversity of Malaga

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

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators