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).

Starting soon · Not applicable · Has a placebo group

Conditions studied: Adult

In brief

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.

Key facts

Study ID

NCT07498881

Run by

University of the Basque Country (UPV/EHU)

People needed

200

Starts

2026-03-30

Expected to finish

2028-03-30

Last updated by the study team

2026-03-27

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Euskal Herriko Unibertsitatea — San Sebastián, Gipuzkoa, Spain

Full record on ClinicalTrials.gov

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