LasaiON is an Evidence-informed, Multimodal Self-regulation Program Designed to Reduce Emotional Distress and Strengthen Stress-regulation Skills by Combining Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) With Breathing Supported by Heart-rate Variability Biofeedback (HRV-B; emWave).
Sponsored by University of the Basque Country (UPV/EHU)
About this trial
Last updated 2 months ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Started a month ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
* Ability to provide written informed consent
* Physically healthy, with no relevant uncontrolled medical condition
* Availability to complete the 5-day study protocol (1 session/day), including baseline and post-intervention assessments
* Intact external ear and suitability for electrode placement on the tragus and acquisition of study recordings (EEG, EDA, HRV)
Exclusion Criteria
* History of cardiovascular disease, diabetes, or hypertension
* Severe bradycardia
* Active implanted electronic device (e.g., pacemaker, cochlear implant, neurostimulator)
* History of vagus nerve transection surgery (cervical vagotomy)
* Pregnancy
* Current or past clinically significant psychiatric disorder
* Current or past clinically significant neurological disorder
* Use of CNS-active medication
* Substance misuse, including nicotine or alcohol
* Dermatitis, infection, or lesions of the ear that could interfere with electrode application
* Ongoing treatment with medications that modulate autonomic nervous system activity or may alter psychophysiological measures (e.g., HRV, EDA, EEG)
