Sleep DisturbancesNEUROSLEEPNCT07371715
Home-Based Auricular Transcutaneous Vagus Nerve Stimulation (tVNS) for Sleep Quality and Psycho-Academic Outcomes in Health Sciences Students
A study testing Auricular Transcutaneous Vagus Nerve Stimulation (tVNS) in people with Sleep Disturbances and Insomnia, run by University of Malaga.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Sleep Disturbances, Insomnia, Stress
- What is being tested?
- Auricular Transcutaneous Vagus Nerve Stimulation (tVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Sleep Disturbances, Insomnia, Stress
- Being tested
- Auricular Transcutaneous Vagus Nerve Stimulation (tVNS), Sham stimulation
- Keywords
- Transcutaneous Vagus Nerve Stimulation, sleep quality, Auricular Stimulation, university students
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Sham stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)
PSQI total score (0-21). Higher scores indicate worse sleep quality.
Measured: Baseline and end of week 3
Anxiety Symptoms (Beck Anxiety Inventory, BAI)
BAI total score. Higher scores indicate greater anxiety symptoms.
Measured: Baseline and end of week 3
Secondary outcomes (5)
Insomnia Severity (Insomnia Severity Index, ISI)
ISI total score. Higher scores indicate greater insomnia severity.
Measured: Baseline and end of week 3
Daytime Sleepiness (Epworth Sleepiness Scale, ESS)
ESS total score. Higher scores indicate greater daytime sleepiness.
Measured: Baseline and end of week 3
Perceived Stress (Perceived Stress Scale-14, PSS-14)
PSS-14 total score. Higher scores indicate greater perceived stress.
Measured: 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.
Measured: 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.
Measured: Baseline and end of semester (up to 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbancesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, two-arm, parallel-group pilot trial (1:1 allocation).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismael Romero García, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371715
- Sponsor's protocol ID
- AURI-tVNS-SLEEP-2026
- Other IDs
- CEIH-UPO: 25/1-17
- Acronym
- NEUROSLEEP
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07371715
- Acronym / sponsor ID
- NEUROSLEEP / AURI-tVNS-SLEEP-2026
- Conditions
- Sleep Disturbances, Insomnia, Stress
- Keywords
- Transcutaneous Vagus Nerve Stimulation, sleep quality, Auricular Stimulation, university students
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled, two-arm, parallel-group pilot trial (1:1 allocation).
| Arm | Type | Receives |
|---|---|---|
| Active tVNS | Experimental | Device: Auricular Transcutaneous Vagus Nerve Stimulation (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. |
| Control (Earlobe Stimulation) | Placebo comparator | Device: Sham stimulationControl 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Active tVNS |
| Sham stimulationControl 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. | Device | Control (Earlobe Stimulation) |
Primary outcome
Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)
Time frame: Baseline and end of week 3
PSQI total score (0-21). Higher scores indicate worse sleep quality.
Anxiety Symptoms (Beck Anxiety Inventory, BAI)
Time frame: Baseline and end of week 3
BAI total score. Higher scores indicate greater anxiety symptoms.
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Transcutaneous Vagus Nerve Stimulation (tVNS) in people with Sleep Disturbances and Insomnia, run by University of Malaga.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ismael Romero Garcia, Principal Investigator (0034651789328, iromero@centrosanisidoro.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (Pittsburgh Sleep Quality Index, PSQI) (time frame: Baseline and end of week 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.