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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).
Sponsor: University of the Basque Country (UPV/EHU)
Summary
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.
Official title: LasaiOn: An Intervention Program to Reduce Emotional Distress
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-03-30
Completion Date
2028-03-30
Last Updated
2026-03-27
Healthy Volunteers
Yes
Conditions
Interventions
LasaiON
Participants will complete one 60-minute session per day. After verification of pre-session requirements, the researcher will place the EEG cap and the HRV, EDA, and EMG sensors and obtain baseline measures. Depending on allocation, participants will receive either active taVNS through stimulation electrodes placed on the auricular target area or sham taVNS using the same device setup without active therapeutic stimulation. From minutes 5-35, participants will remain seated while physiological activity is continuously recorded and they view segmented material from Our Oceans. From minutes 35-50, those allocated to active HRV-biofeedback will use the Coherence Coach platform to learn and practice slow breathing at 6 breaths/min, whereas control participants will observe their physiological activity on screen without guided breathing training. Each night at home, intrusive thoughts will be recorded through a brief Google Forms self-report and later analyzed with IRaMuTeQ.
Locations (1)
Euskal Herriko Unibertsitatea
San Sebastián, Gipuzkoa, Spain