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

Launched by XIDIAN UNIVERSITY · Sep 24, 2024

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, ...

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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.