Not Yet RecruitingNot Applicable

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

60 participantsStarted 2026-03-01

Plain-language summary

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.

Who can participate

Age range18 Years – 35 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. * Ability to understand study procedures and provide written informed consent. * Willing and able to self-administer the intervention at home and complete study questionnaires. Exclusion Criteria: * 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. * Pregnancy. * Ear infection, skin lesions, or dermatologic condition preventing electrode placement. * Hypersensitivity or intolerance to electrical stimulation. * Participation in another clinical trial within the last 30 days.

What they're measuring

Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)

Timeframe: Baseline and end of week 3

Anxiety Symptoms (Beck Anxiety Inventory, BAI)

Timeframe: Baseline and end of week 3

Trial details

NCT IDNCT07371715

SponsorUniversity of Malaga

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-01

Contact for this trial

Ismael Romero Garcia, Principal Investigator

0034651789328 iromero@centrosanisidoro.es