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).

ConditionAdult
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of the Basque Country (UPV/EHU)

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

200 Participants
are divided into 4 treatment groups

Sponsors and collaborators