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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Xi'an, Shaanxi, China
Patients applied
Trial Officials
Qin Wei, Phd
Principal Investigator
Xidian University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported