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

NCT07371715 | Not Yet Recruiting

• 2 other identifiers: AURI-tVNS-SLEEP-2026CEIH-UPO: 25/1-17
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Insomnia; Sleep Disturbances; Stress

Keywords

Transcutaneous Vagus Nerve Stimulation; sleep quality; Auricular Stimulation; university students

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Insomnia Severity (Insomnia Severity Index, ISI)

  Baseline and end of week 3

• Daytime Sleepiness (Epworth Sleepiness Scale, ESS)

  Baseline and end of week 3

• Perceived Stress (Perceived Stress Scale-14, PSS-14)

  Baseline and end of week 3

• Quality of Life (12-Item Short Form Survey, SF-12 v2)

  Baseline and end of week 3

• Academic Performance (GPA and Credits Passed)

  Baseline and end of semester (up to 16 weeks)

Study Arms (2)

Active tVNS

EXPERIMENTAL

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)

Control (Earlobe Stimulation)

PLACEBO COMPARATOR

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

Interventions

Auricular Transcutaneous Vagus Nerve Stimulation (tVNS) DEVICE

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.

Active tVNS

Sham stimulation DEVICE

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.

Control (Earlobe Stimulation)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Central Study Contacts

Ismael Romero Garcia, Principal Investigator

CONTACT

0034651789328; iromero@centrosanisidoro.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded to group allocation. Outcome assessors and data analysts are blinded to treatment assignment. The control condition consists of stimulation applied to the earlobe to mimic sensory stimulation without active auricular vagal stimulation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator / PhD Candidate

Model Details: Randomized, controlled, two-arm, parallel-group pilot trial (1:1 allocation).

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 28, 2026
• Study Start: March 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share