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Not yet recruiting NCT07371715

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

No phase Interventional Sleep Disturbances Insomnia Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Auricular Transcutaneous Vagus Nerve Stimulation (tVNS), Sham stimulation.
Who it may be relevant to
Registry conditions: Sleep Disturbances, Insomnia, Stress. Basic parameters: 18 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Sleep Quality (Pittsburgh Sleep Quality Index, PSQI) [Time frame: Baseline and end of week 3]
  • Anxiety Symptoms (Beck Anxiety Inventory, BAI) [Time frame: Baseline and end of week 3]
Secondary outcome measures (5)
  • Insomnia Severity (Insomnia Severity Index, ISI) [Time frame: Baseline and end of week 3]
  • Daytime Sleepiness (Epworth Sleepiness Scale, ESS) [Time frame: Baseline and end of week 3]
  • Perceived Stress (Perceived Stress Scale-14, PSS-14) [Time frame: Baseline and end of week 3]
  • Quality of Life (12-Item Short Form Survey, SF-12 v2) [Time frame: Baseline and end of week 3]
  • Academic Performance (GPA and Credits Passed) [Time frame: Baseline and end of semester (up to 16 weeks)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07371715 · AURI-tVNS-SLEEP-2026 · CEIH-UPO: 25/1-17

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗