About this trial
The goal of this clinical trial is to evaluate whether the LasaiON program, which combines transcutaneous auricular vagus nerve stimulation (taVNS) with breathing supported by heart rate variability biofeedback (HRV-B; emWave), reduces emotional distress and improves stress-regulation processes in adults. The study will also assess the safety, tolerability, and feasibility of the intervention.
The main questions it aims to answer are:
1. Does the LasaiON program reduce emotional distress in adults? 2. What physiological, psychological, and verbal-cognitive changes are observed following the intervention? 3. What discomforts, adverse effects, or tolerability issues do participants experience during the program?
Researchers will use a prospective 2 × 2 factorial randomized controlled design to examine the effects of stimulation condition (active taVNS vs. sham taVNS) and training condition (active HRV-biofeedback vs. control training), as well as their potential interaction. Participants will be randomly allocated in equal proportions (1:1:1:1) to one of four groups: sham taVNS + control training, sham taVNS + HRV-biofeedback, active taVNS + control training, or active taVNS + HRV-biofeedback.
Participants will:
* undergo baseline assessments on Day 1 before the intervention; * complete 5 consecutive daily 60-minute sessions according to group allocation; * undergo post-intervention assessments on Day 5 after the final session; * complete psychometric, physiological, and verbal-cognitive assessments, including STAI, HAM-D, WHO-5, EEG, skin conductance, startle response, heart rate variability measures derived using Kubios HRV Premium, and daily five-word reports with valence ratings analyzed using IRaMuTeQ; * have adherence and tolerability recorded at each session using a checklist.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- LasaiON
Treatment groups
Sponsors and collaborators
University of the Basque Country (UPV/EHU)
Lead sponsor
Parasym Ltd.
Collaborator