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Investigating the Efficacy of Auricular Vagus Nerve Stimulation in Counteracting Fatigue and Enhancing Cognition under High-Altitude Exposure

Investigating the Efficacy of Auricular Vagus Nerve Stimulation in Counteracting Fatigue and Enhancing Cognition under High-Altitude Exposure

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112985
Enrollment
Unknown
Registered
2025-11-21
Start date
2025-11-21
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

none

Interventions

Rapid Ascent taVNS Group:Auricular Vagus Nerve Stimulation
Rapid Ascent Sham Group:Earlobe Vagus Nerve Stimulation
Resident taVNS Group:Auricular Vagus Nerve Stimulation
Resident Sham Group:Earlobe Vagus Nerve Stimulation

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 45 years, regardless of gender. 2. Body Mass Index (BMI) between 18.5 and 28.0 kg/m² (to exclude the influence of obesity or malnutrition on physiological indicators). 3. For rapid-ascent populations: No history of high-altitude exposure (defined as no stay exceeding 24 hours in an environment above 3000m). For resident populations: High-altitude exposure (above 3000m) for at least 3 months (to avoid the residual stress effects of rapid ascent). 4. Confirmed to be in good health without severe underlying diseases, as verified through physical examination (blood pressure, heart rate, cardiopulmonary auscultation) and laboratory tests (complete blood count, liver and kidney function). 5. Normal hearing (able to understand trial instructions clearly), and no deformities, inflammation, or trauma of the auricle (to ensure proper electrode placement). 6. No history of neurological or psychiatric disorders (e.g., epilepsy, depression, anxiety disorders, schizophrenia, etc.) and no history of cardiovascular diseases (e.g., hypertension, coronary heart disease, arrhythmia, etc.). 7. No intake of any medications affecting central nervous or autonomic nervous system function (e.g., sedative-hypnotics, antidepressants, beta-blockers, etc.) within one month prior to the trial. 8. No history of staying up late, strenuous exercise, alcohol consumption, or coffee intake within one week prior to the trial; and agreement to avoid staying up late, strenuous exercise, alcohol, coffee, and tea consumption throughout the trial period. 9. Voluntarily signs the informed consent form and is able to cooperate to complete the entire trial process (including high-altitude exposure, taVNS intervention, and multiple testing sessions).

Exclusion criteria

Exclusion criteria: 1. Age 45 years. 2. BMI 28.0 kg/m². 3. For rapid-ascent populations: Any history of high-altitude exposure. For resident populations: High-altitude exposure of less than 3 months. 4. Presence of severe cardiopulmonary diseases (e.g., chronic obstructive pulmonary disease, congenital heart disease), hepatic or renal dysfunction, or hematological diseases (e.g., anemia, leukemia). 5. Diagnosis of neurological or psychiatric disorders. 6. Presence of auricular deformity, inflammation, unhealed trauma, or allergy to metal electrodes. 7. Implantation of electronic medical devices (e.g., cardiac pacemakers, insulin pumps) to avoid potential interference from taVNS stimulation with device function. 8. Use of medications known to affect neurological function or oxygen metabolism within one month prior to the trial. 9. Pregnancy or lactation (to avoid any potential unknown effects on the fetus or infant). 10. Inability to cooperate with the completion of the trial procedures or refusal to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Electrocardiogram;Electroencephalogram;Photoplethysmography;SpO2;RSP;Lake Louise Score;Fatigue Severity Scale;Cognitive Function Assessment;

Countries

China

Contacts

Public ContactHongyun Liiu

Chinese PLA General Hospital

ylooliu@163.com+86 150 0114 8914

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026