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Search / Trial NCT06614803

Study of the Effects of Transcutaneous Auricular Vagus Nerve Stimulation Combined with Slow Breathing on Insomnia

Launched by XIDIAN UNIVERSITY · Sep 24, 2024

Trial Information

Current as of June 21, 2025

Completed

Keywords

Insomnia Interoception Transcutaneous Auricular Vagus Nerve Stimulation Slow Breathing

ClinConnect Summary

This study conducted a randomized controlled clinical trial with an intention to enroll 80 insomnia participants. Participants were randomly assigned in a 1:1:1:1 ratio to four groups:1)taVNS combined with slow breathing group;2)taVNS with normal breathing group;3)slow breathing with sham taVNS group;4)normal breathing with sham taVNS group.The study included a one-week baseline period, a two-week treatment period, and a two-week follow-up period. During the 2-week treatment period, 20 minutes of continuous treatment was performed every evening. The stimulation parameters were set to 20Hz, ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age over 18 years;
  • 2. Meet the definition of insomnia in the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V);
  • 3. Has not received any psychotropic drug treatment;
  • 4. PSQI(Pittsburgh Sleep Quality Index) score\>7;
  • 5. ISI(Insomnia Severity Index) score≥11;
  • 6. Signed informed consent form;
  • 7. Ability and willingness to comply with the study requirements.
  • Exclusion Criteria:
  • 1. There are learning or working hours that affect the circadian rhythm;
  • 2. There is abuse of alcohol, nicotine, or other substances;
  • 3. Pregnancy, breastfeeding, or plans to become pregnant;
  • 4. Damage or allergy to the selected stimulation site;
  • 5. Clinically diagnosed mental disorders and other medical conditions;
  • 6. Currently taking stimulant, hormone, or other medications that may cause insomnia and are not suitable for discontinuation.

About Xidian University

Xidian University is a prominent research institution located in Xi'an, China, renowned for its commitment to advancing technology and innovation in various fields, including biomedical research. As a clinical trial sponsor, Xidian University leverages its strong academic foundation and interdisciplinary expertise to facilitate groundbreaking studies aimed at improving healthcare outcomes. The university is dedicated to ethical research practices, ensuring participant safety and regulatory compliance, while fostering collaborations with industry partners and healthcare professionals to translate scientific discoveries into practical applications. Through its clinical trials, Xidian University strives to contribute valuable insights to the medical community and enhance the quality of life for patients.

Locations

Xi'an, Shaanxi, China

Patients applied

0 patients applied

Trial Officials

Qin Wei, Phd

Principal Investigator

Xidian University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported