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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress; Insomnia; Sleep Disturbances
• Intervention / Treatment: Device: Auricular Transcutaneous Vagus Nerve Stimulation (tVNS); Device: Sham stimulation

Detailed Description

Sleep disturbances are highly prevalent among university students and are frequently associated with academic stress and impaired psycho-academic functioning. Transcutaneous vagus nerve stimulation (tVNS) is a non-invasive neuromodulation approach with potential to modulate autonomic function and stress responses, which may contribute to improvements in sleep quality.

This study is designed as a randomized controlled pilot trial to assess the efficacy, safety, and feasibility of a home-based auricular tVNS intervention in Health Sciences university students. Eligible participants will be aged 18-35 years and will present poor sleep quality (PSQI > 7) and primary insomnia criteria. Participants will be recruited from two academic centers (University of Malaga and Centro Universitario San Isidoro, affiliated with Pablo de Olavide University, Seville) and will be randomly allocated (1:1) to one of two arms: (1) active auricular stimulation targeting the left cymba conchae (with tragus as an alternative if needed), or (2) control (sham) stimulation delivered to the ipsilateral earlobe. Randomization will be performed using block randomization, and outcome assessors and data analysts will remain blinded to group assignment.

The intervention will be delivered at home using a low-frequency TENS-like device with biphasic symmetrical waveform (25 Hz, 200 μs pulse width), administered for 60 minutes per session, 5 sessions per week for 3 weeks. Stimulation intensity will be individually adjusted to achieve a clear but comfortable paresthetic sensation below the pain threshold. Adherence will be monitored using an electronic diary with time stamps and daily photographic verification of electrode placement.

The primary outcome is sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI) pre- and post-intervention. Secondary outcomes include insomnia severity (ISI), daytime sleepiness (ESS), perceived stress (PSS-14), anxiety measures (e.g., BAI and HAMA), depressive symptoms (HAMD), fatigue (FFS), and health-related quality of life (SF-12 v2). Psycho-academic outcomes will be measured using self-reported GPA and credits passed at the end of the semester. Safety will be assessed through systematic recording of adverse events throughout the intervention period.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ismael Romero Garcia, Principal Investigator; Phone Number: 0034651789328; Email: iromero@centrosanisidoro.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active tVNS; Home-based auricular transcutaneous vagus nerve stimulation (tVNS) applied to the left cymba conchae (or tragus if needed) using a low-frequency TENS-like device. Sessions are performed for 60 minutes, 5 days/week for 3 weeks. Stimulation intensity is adjusted to a strong but comfortable paresthesia below pain threshold.	Device: 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.
Placebo Comparator: Control (Earlobe Stimulation); Control stimulation delivered to the ipsilateral earlobe using the same device and schedule as the active intervention (60 minutes, 5 days/week for 3 weeks) to mimic sensory stimulation without targeting auricular vagal afferents.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)	PSQI total score (0-21). Higher scores indicate worse sleep quality.	Baseline and end of week 3
Anxiety Symptoms (Beck Anxiety Inventory, BAI)	BAI total score. Higher scores indicate greater anxiety symptoms.	Baseline and end of week 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity (Insomnia Severity Index, ISI)	ISI total score. Higher scores indicate greater insomnia severity.	Baseline and end of week 3
Daytime Sleepiness (Epworth Sleepiness Scale, ESS)	ESS total score. Higher scores indicate greater daytime sleepiness.	Baseline and end of week 3
Perceived Stress (Perceived Stress Scale-14, PSS-14)	PSS-14 total score. Higher scores indicate greater perceived stress.	Baseline and end of week 3
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.	Baseline and end of week 3
Academic Performance (GPA and Credits Passed)	Self-reported grade point average (GPA) and number of credits passed during the academic term.	Baseline and end of semester (up to 16 weeks)

Collaborators and Investigators

• Sponsor: University of Malaga

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 23, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: university students; sleep quality; Transcutaneous Vagus Nerve Stimulation; Auricular Stimulation
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Parasomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: AURI-tVNS-SLEEP-2026; CEIH-UPO: 25/1-17 (Other Identifier: Ethics Committee Approval Code (CEIH, UPO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared publicly due to data protection regulations and participant privacy requirements. Study results will be reported in aggregate form. De-identified data may be made available upon reasonable request and with approval from the investigators and the ethics committee, in accordance with applicable regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No