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Home-Based Auricular Transcutaneous Vagus Nerve Stimulation (tVNS) for Sleep Quality and Psycho-Academic Outcomes in Health Sciences Students
Sponsor: University of Malaga
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.
Official title: Efficacy, Safety, and Feasibility of a Home-Based Auricular Transcutaneous Electrical Stimulation Intervention Using a Low-Frequency TENS-Like Device to Improve Sleep Quality and Psycho-Academic Outcomes in Health Sciences Students: A Randomized Controlled Pilot Study
Key Details
Gender
All
Age Range
18 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-03-01
Completion Date
2026-06-01
Last Updated
2026-01-28
Healthy Volunteers
No
Conditions
Interventions
Auricular Transcutaneous Vagus Nerve Stimulation (tVNS)
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
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.