AdultLasaiONNCT07498881
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).
A study testing LasaiON in people with Adult, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Adult
- What is being tested?
- LasaiON
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 30 Mar 2026to 30 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Euskal Herriko Unibertsitatea
San Sebastián, Gipuzkoa, 20018
Ainara Aranberri Ruiz, Ph.D., 943018311, ainara.aranberri@ehu.eus
Unai Liberal Graña, PhD, 943 01 5224, unai.liberal@ehu.eus
About this study
Official title: LasaiOn: An Intervention Program to Reduce Emotional Distress
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:
Read more
- Does the LasaiON program reduce emotional distress in adults?
- What physiological, psychological, and verbal-cognitive changes are observed following the intervention?
- 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.
Read the detailed description
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). The study is designed to evaluate the effects of stimulation condition and training condition on psychophysiological, psychological, and verbal-cognitive outcomes in adults.
This study is a prospective randomized controlled trial with a 2 × 2 factorial design. The two experimental factors are stimulation condition (active taVNS vs. sham taVNS) and training condition (active HRV-biofeedback training vs. control training). 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 training, active taVNS + control training, or active taVNS + HRV-biofeedback training. This design will allow estimation of the main effects of stimulation and training, as well as their potential interaction.
The intervention will be delivered over 5 consecutive days. Participants will complete one 60-minute session per day in an individual format under researcher supervision. Baseline assessments will be performed on Day 1 before the intervention begins, and post-intervention assessments will be performed on Day 5 after completion of the final session.
During each session, participants will remain comfortably seated in front of a computer in a standardized setting. According to group allocation, they will receive active or sham taVNS and active HRV-biofeedback training or control training. The procedures are designed to be non-invasive and are expected to be well tolerated. Session delivery will follow a standardized protocol to ensure consistency across participants and conditions.
Before each session, pre-session requirements will be checked. Participants will be asked to avoid alcohol and strenuous exercise in the previous 12 hours, to avoid caffeine and nicotine before the session, and to avoid substances or medications that may substantially alter autonomic nervous system functioning, in accordance with protocol requirements. If necessary, deviations or incidents affecting the session will be recorded.
Psychometric, psychophysiological, and verbal-cognitive assessments will be collected at baseline and post-intervention. Psychometric measures will assess anxiety, depressive symptoms, and emotional well-being. Psychophysiological measures will include electroencephalographic activity (EEG), skin conductance, startle response, and heart rate variability (HRV). HRV will be recorded using the emWave system and analyzed using Kubios HRV Premium. Derived HRV measures will include RMSSD, SDNN, HF power, LF power, LF/HF ratio, PNS index, and SNS index. Verbal-cognitive assessment will include daily five-word self-reports describing the participant's current state, together with valence ratings, analyzed using IRaMuTeQ.
In addition to baseline and post-intervention assessments, participants will complete a brief daily digital self-report during the intervention period. This record will include five words describing their current state and a valence rating for each word. These data are intended to capture subjective verbal-cognitive changes across the intervention period using a standardized and minimally burdensome procedure.
Adherence, tolerability, and safety will be monitored throughout the study. At each session, researchers will record session completion, duration, deviations, and any relevant incidents. Participants will complete a brief checklist assessing comfort, tolerability, ease of use, and any discomfort associated with the assigned procedures. Any adverse events, unusual sensations, interruptions, or reasons for withdrawal will be documented systematically.
Recruitment will be continuous, with sequential enrollment expected over approximately 24 months. All sessions and assessments will be conducted at the Faculty of Psychology, Ibaeta Campus, University of the Basque Country (UPV/EHU). The study is conducted under the supervision of the research team led by Ainara Aranberri Ruiz, and all study procedures will be carried out confidentially and in accordance with applicable ethical requirements.
- Conditions
- Adult
- Being tested
- LasaiON
- Keywords
- slow, paced breathing, transauricualr vagus nerve stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LasaiONCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham taVNS + HRV-Biofeedback Training | Experimental | Participants assigned to this arm will receive sham taVNS together with active HRV-biofeedback training over 5 consecutive intervention days, with one supervised 60-minute session per day. In each session, participants will sit comfortably in front of a computer. A sham taVNS device will be positioned at the tragus but will not deliver active electrical stimulation, while heart rate variability biofeedback will be provided through an ear sensor connected to the emWave platform. Sessions will include a brief pre-session checklist, fitting of psychophysiological recording equipment (EEG, HRV, EDA/EMG), a short quiet baseline, approximately 10 minutes of slow paced breathing (~6 breaths/min) supported by Coherence Coach, followed by post-session tolerability/comfort ratings. This arm is designed to isolate the effect of active HRV-biofeedback training in the absence of active taVNS. Receives: Combination Product: LasaiON |
| Active taVNS + Control Training | Experimental | Participants assigned to this arm will receive active transcutaneous auricular vagus nerve stimulation (taVNS) combined with control training across five consecutive intervention days, with one supervised 60-minute session per day. During each session, participants will be seated comfortably in front of a computer. Active taVNS will be delivered at the tragus, while the training component will consist of a control condition without the Coherence Coach application, rather than active HRV biofeedback. Sessions will include a brief pre-session checklist, fitting of psychophysiological recording equipment (EEG, HRV, and EDA/EMG), a short resting baseline, and post-session ratings of tolerability and comfort. This arm is intended to isolate the effect of active taVNS in the absence of active HRV biofeedback training. Receives: Combination Product: LasaiON |
| Active taVNS + HRV-Biofeedback Training | Experimental | Participants assigned to this arm will receive the full active LasaiON intervention over 5 consecutive intervention days, with one supervised 60-minute session per day. In each session, participants will sit comfortably in front of a computer while receiving active transcutaneous auricular vagus nerve stimulation (taVNS) at the tragus together with active heart rate variability biofeedback (HRV-biofeedback) breathing training supported by the emWave platform. Sessions will include a brief pre-session checklist, fitting of psychophysiological recording equipment (EEG, HRV, EDA/EMG), a short quiet baseline, delivery of both active intervention components, and post-session tolerability/comfort ratings. This arm is designed to evaluate the combined effect of active taVNS and active HRV-biofeedback training and to determine whether their combination produces greater benefits than either component alone or than the fully control condition. Receives: Combination Product: LasaiON |
| sham taVNS+control training | Sham comparator | This control condition is delivered over 5 consecutive days, with one supervised 60-minute session per day, and is designed to match the active intervention in schedule, setting, and researcher contact without providing the active therapeutic components. Participants attend the sessions in the same standardized format, but the sham taVNS device placed at the tragus does not deliver active electrical stimulation, and the training condition does not include active HRV-biofeedback or the paced-breathing training intended to consolidate a respiratory rhythm of approximately 6 breaths per minute. This condition is intended to control for expectancy, procedural context, and time spent in session while withholding both active taVNS and active HRV-biofeedback training. Receives: Combination Product: LasaiON |
What is being measured
The primary outcome is the main question the study is designed to answer.
State anxiety score
Change in state anxiety assessed with the State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-State). Scores range from 20 to 80, with higher scores indicating greater anxiety.
Measured: From baseline (day 1) to post-intervention (day 5)
Depressive symptom score
Change in depressive symptoms assessed with the 17-item Hamilton Depression Rating Scale (HAM-D). Scores range from 0 to 52, with higher scores indicating greater depressive symptom severity.
Measured: From baseline (day 1) to post-intervention (day5)
WHO-5 well-being score
Change in emotional well-being assessed with the World Health Organization-Five Well-Being Index (WHO-5). Raw scores range from 0 to 25, with higher scores indicating better emotional well-being.
Measured: From baseline (day 1) to post-intervention (day 5)
Change in RMSSD
Change in heart rate variability assessed by the root mean square of successive differences (RMSSD) using Kubios HRV software. RMSSD reflects beat-to-beat variability in heart rate and is reported in milliseconds (ms). Higher values indicate greater vagally mediated heart rate variability, whereas lower values indicate lower vagally mediated heart rate variability.
Measured: from baseline (day 1) to post-intervention (day 5)
Change in skin conductance level
Change in physiological arousal assessed by skin conductance level, measured in microsiemens (µS). Higher values indicate greater sympathetic arousal.
Measured: From baseline (day 1) to post-intervention (day 5)
Change in startle response amplitude
Change in physiological reactivity assessed by the peak amplitude of the acoustic startle eyeblink response, recorded from the orbicularis oculi muscle using electromyography (EMG). Startle amplitude will be defined as the peak EMG response occurring within 20 to 150 milliseconds after startle probe onset relative to the mean 50-millisecond pre-probe baseline. Amplitude will be reported in microvolts (µV), with higher values indicating greater physiological reactivity.
Measured: From baseline (day 1) to post-intervention (day 5)
Change in frontal midline theta band power at Fz
Change in frontal midline theta band power at Fz, recorded using the 8-channel Unicorn Hybrid Black electroencephalography (EEG) system. EEG data will be acquired at 250 Hz per channel and analyzed as absolute spectral power in the theta frequency band (4-8 Hz). Theta band power will be reported in microvolts squared per hertz (µV²/Hz). Higher values indicate greater frontal midline theta band power.
Measured: from baseline (day 1) to post-intervention (day 5)
Change in frequency of intrusive-thought-related lexical occurrences
Change in intrusive thoughts assessed by counting prespecified intrusive-thought-related lexical occurrences in written self-reports using IRaMuTeQ text analysis software. Frequency will be reported as the number of intrusive-thought-related lexical occurrences per written self-report. A value of 0 indicates no intrusive-thought-related lexical occurrences, and higher values indicate greater intrusive-thought-related lexical content.
Measured: from baseline (day 1) to post-intervention (day 5)
Change in SDNN
Change in heart rate variability assessed by the standard deviation of normal-to-normal RR intervals (SDNN) using Kubios HRV software. SDNN reflects overall heart rate variability, including both short-term and longer-term components, and is reported in milliseconds (ms). Higher values indicate greater overall heart rate variability, whereas lower values indicate lower overall heart rate variability.
Measured: From baseline (day 1) to post-intervention (day 5)
Change in high-frequency power
Change in heart rate variability assessed by high-frequency (HF) power using Kubios HRV software. HF power reflects high-frequency heart rate variability and will be reported as absolute power in milliseconds squared (ms²). Higher values generally indicate greater vagally mediated, parasympathetic modulation of heart rate variability.
Measured: From baseline (day 1) to post-intervention (day 5)
Change in low-frequency power
Change in heart rate variability assessed by low-frequency (LF) power using Kubios HRV software. LF power reflects low-frequency heart rate variability and will be reported as absolute power in milliseconds squared (ms²). Higher values indicate greater low-frequency heart rate variability.
Measured: From baseline (day 1) to post-intervention (day 5)
Change in LF/HF ratio
Change in heart rate variability assessed by the ratio of low-frequency to high-frequency power (LF/HF) using Kubios HRV software. The LF/HF ratio will be reported as a unitless ratio. Higher values indicate a higher ratio of low-frequency to high-frequency power.
Measured: From baseline (day 1) to post-intervention (day 5)
Change in PNS index
Change in autonomic function, assessed using the parasympathetic nervous system (PNS) index obtained from Kubios HRV software. In Kubios, a value of 0 reflects autonomic activity comparable to the normative population mean; positive values indicate higher parasympathetic activity, whereas negative values indicate lower parasympathetic activity.
Measured: From baseline (day 1) to post-intervention (day 5)
Change in SNS index
Change in autonomic function assessed by the sympathetic nervous system (SNS) index using Kubios HRV software. In Kubios, a value of 0 indicates values comparable to the normal population average; positive values indicate above-average sympathetic activity, and negative values indicate below-average sympathetic activity.
Measured: From baseline (day 1) to post-intervention (day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start30 Mar 2026 (estimated)
- Primary completion3 Sep 2026 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This study uses a 2 × 2 factorial randomized controlled design to evaluate the independent and combined effects of stimulation and training. The two intervention factors are stimulation condition (active transcutaneous auricular vagus nerve stimulation \[taVNS\] vs. sham taVNS) and training condition (active heart rate variability biofeedback \[HRV-biofeedback\] vs. control training). Participants will be randomly assigned in equal proportions (1:1:1:1) to one of four parallel groups: sham taVNS + control training, sham taVNS + HRV-biofeedback, active taVNS + control training, or active taVNS + HRV-biofeedback. This model allows estimation of the main effects of each factor and their interaction. Assessments will be performed at baseline (Day 1, pre-intervention) and post-intervention (Day 5, after the final session).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Basque Country (UPV/EHU)
- Sponsor type
- University, hospital or other
- Collaborators
- Parasym Ltd.
- Responsible party
- Principal investigator, Ainara Aranberri Ruiz, University of the Basque Country (UPV/EHU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498881
- Sponsor's protocol ID
- M10/2026/055. March 2, 2026
- Acronym
- LasaiON
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be anonymized and will not be shared with third parties. The dataset will be registered at the University of the Basque Country (UPV/EHU) under the following data-processing record, in accordance with the EU General Data Protection Regulation (GDPR; Regulation (EU) 2016/679): data-processing code TI0741-1471 ; name of the data-processing activity: LasaiON
Publications
Zhang Y, Lin P, Wang R, Zhou J, Xu X, Jiang W, Pu X, Ge S. Insula-Medial Prefrontal Cortex Functional Connectivity Modulated by Transcutaneous Auricular Vagus Nerve Stimulation: An fMRI Study. IEEE J Biomed Health Inform. 2024 Oct;28(10):5962-5970. doi: 10.1109/JBHI.2024.3423019. Epub 2024 Oct 3.
PubMed 38963749Dormal V, Vermeulen N, Mejias S. Is heart rate variability biofeedback useful in children and adolescents? A systematic review. J Child Psychol Psychiatry. 2021 Dec;62(12):1379-1390. doi: 10.1111/jcpp.13463. Epub 2021 Jun 21.
PubMed 34155631Tian QQ, Cheng C, Yin ZX, Yuan YY, Wang C, Zeng X, Sun JB, Yang Q, Yang XJ, Qin W. Combined transcutaneous auricular vagus stimulation (taVNS) with 0.1Hz slow breathing enhances insomnia treatment efficacy: A pilot study. Brain Stimul. 2024 Jan-Feb;17(1):4-6. doi: 10.1016/j.brs.2023.11.015. Epub 2023 Nov 30. No abstract available.
PubMed 38042286Napadow V, Edwards RR, Cahalan CM, Mensing G, Greenbaum S, Valovska A, Li A, Kim J, Maeda Y, Park K, Wasan AD. Evoked pain analgesia in chronic pelvic pain patients using respiratory-gated auricular vagal afferent nerve stimulation. Pain Med. 2012 Jun;13(6):777-89. doi: 10.1111/j.1526-4637.2012.01385.x. Epub 2012 May 8.
PubMed 22568773McAllister-Williams RH, Sousa S, Kumar A, Greco T, Bunker MT, Aaronson ST, Conway CR, Rush AJ. The effects of vagus nerve stimulation on the course and outcomes of patients with bipolar disorder in a treatment-resistant depressive episode: a 5-year prospective registry. Int J Bipolar Disord. 2020 May 2;8(1):13. doi: 10.1186/s40345-020-0178-4.
PubMed 32358769Kim AY, Marduy A, de Melo PS, Gianlorenco AC, Kim CK, Choi H, Song JJ, Fregni F. Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Sci Rep. 2022 Dec 21;12(1):22055. doi: 10.1038/s41598-022-25864-1.
PubMed 36543841Thabrew H, Ruppeldt P, Sollers JJ 3rd. Systematic Review of Biofeedback Interventions for Addressing Anxiety and Depression in Children and Adolescents with Long-Term Physical Conditions. Appl Psychophysiol Biofeedback. 2018 Sep;43(3):179-192. doi: 10.1007/s10484-018-9399-z.
PubMed 29946920Goessl VC, Curtiss JE, Hofmann SG. The effect of heart rate variability biofeedback training on stress and anxiety: a meta-analysis. Psychol Med. 2017 Nov;47(15):2578-2586. doi: 10.1017/S0033291717001003. Epub 2017 May 8.
PubMed 28478782Garcia RG, Cohen JE, Stanford AD, Gabriel A, Stowell J, Aizley H, Barbieri R, Gitlin D, Napadow V, Goldstein JM. Respiratory-gated auricular vagal afferent nerve stimulation (RAVANS) modulates brain response to stress in major depression. J Psychiatr Res. 2021 Oct;142:188-197. doi: 10.1016/j.jpsychires.2021.07.048. Epub 2021 Aug 2.
PubMed 34365067Fang J, Rong P, Hong Y, Fan Y, Liu J, Wang H, Zhang G, Chen X, Shi S, Wang L, Liu R, Hwang J, Li Z, Tao J, Wang Y, Zhu B, Kong J. Transcutaneous Vagus Nerve Stimulation Modulates Default Mode Network in Major Depressive Disorder. Biol Psychiatry. 2016 Feb 15;79(4):266-73. doi: 10.1016/j.biopsych.2015.03.025. Epub 2015 Apr 2.
PubMed 25963932Umac EH, Semerci R. Effect of Biofeedback-Based Interventions on the Psychological Outcomes of Pediatric Populations: A Systematic Review and Meta-analysis. Appl Psychophysiol Biofeedback. 2023 Sep;48(3):299-310. doi: 10.1007/s10484-023-09583-5. Epub 2023 Apr 4.
PubMed 37016184Darabi MD, Silber SP, Slotkin R, Peechatka AL. Biofeedback-based Digital Games and Well-being in Childhood: A Systematic Review. Res Child Adolesc Psychopathol. 2025 Dec;53(12):2115-2130. doi: 10.1007/s10802-025-01387-x. Epub 2025 Nov 20.
PubMed 41261293Cui Y, Sun J, Zhang B, Guo T, Zhang S, Li Z, Chen Y, Su M, Wu D, Wu J, Wang Q, Yuan Y, Wang J, Tian Q, He F, Wu L, Li X, Gong Y, Qin W. Efficacy and safety of transcutaneous auricular vagus nerve stimulation for patients with treatment-resistant schizophrenia with predominantly negative symptoms: a randomized clinical trial and efficacy sensitivity biomarkers. Mol Psychiatry. 2025 Nov;30(11):5437-5447. doi: 10.1038/s41380-025-03132-8. Epub 2025 Aug 26.
PubMed 40858781Austelle CW, Cox SS, Connolly DJ, Baker Vogel B, Peng X, Wills K, Sutton F, Tucker KB, Ashley E, Manett A, Cortese B, Short EB, Badran BW. Accelerated Transcutaneous Auricular Vagus Nerve Stimulation for Inpatient Depression and Anxiety: The iWAVE Open Label Pilot Trial. Neuromodulation. 2025 Jun;28(4):672-681. doi: 10.1016/j.neurom.2025.02.003. Epub 2025 Mar 19.
PubMed 40117415Aranberri Ruiz A. Transcutaneous Auricular Vagus Nerve Stimulation to Improve Emotional State. Biomedicines. 2024 Feb 9;12(2):407. doi: 10.3390/biomedicines12020407.
PubMed 38398009
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LasaiOn: An Intervention Program to Reduce Emotional Distress
- ClinicalTrials.gov ID
- NCT07498881
- Acronym / sponsor ID
- LasaiON / M10/2026/055. March 2, 2026
- Conditions
- Adult
- Keywords
- slow, paced breathing, transauricualr vagus nerve stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of the Basque Country (UPV/EHU)University, hospital or other
- Collaborators
- Parasym Ltd.
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 3 Sep 2026 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the LasaiON program reduce emotional distress in adults?
- What physiological, psychological, and verbal-cognitive changes are observed following the intervention?
- 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.
Detailed description
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). The study is designed to evaluate the effects of stimulation condition and training condition on psychophysiological, psychological, and verbal-cognitive outcomes in adults.
This study is a prospective randomized controlled trial with a 2 × 2 factorial design. The two experimental factors are stimulation condition (active taVNS vs. sham taVNS) and training condition (active HRV-biofeedback training vs. control training). 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 training, active taVNS + control training, or active taVNS + HRV-biofeedback training. This design will allow estimation of the main effects of stimulation and training, as well as their potential interaction.
The intervention will be delivered over 5 consecutive days. Participants will complete one 60-minute session per day in an individual format under researcher supervision. Baseline assessments will be performed on Day 1 before the intervention begins, and post-intervention assessments will be performed on Day 5 after completion of the final session.
During each session, participants will remain comfortably seated in front of a computer in a standardized setting. According to group allocation, they will receive active or sham taVNS and active HRV-biofeedback training or control training. The procedures are designed to be non-invasive and are expected to be well tolerated. Session delivery will follow a standardized protocol to ensure consistency across participants and conditions.
Before each session, pre-session requirements will be checked. Participants will be asked to avoid alcohol and strenuous exercise in the previous 12 hours, to avoid caffeine and nicotine before the session, and to avoid substances or medications that may substantially alter autonomic nervous system functioning, in accordance with protocol requirements. If necessary, deviations or incidents affecting the session will be recorded.
Psychometric, psychophysiological, and verbal-cognitive assessments will be collected at baseline and post-intervention. Psychometric measures will assess anxiety, depressive symptoms, and emotional well-being. Psychophysiological measures will include electroencephalographic activity (EEG), skin conductance, startle response, and heart rate variability (HRV). HRV will be recorded using the emWave system and analyzed using Kubios HRV Premium. Derived HRV measures will include RMSSD, SDNN, HF power, LF power, LF/HF ratio, PNS index, and SNS index. Verbal-cognitive assessment will include daily five-word self-reports describing the participant's current state, together with valence ratings, analyzed using IRaMuTeQ.
In addition to baseline and post-intervention assessments, participants will complete a brief daily digital self-report during the intervention period. This record will include five words describing their current state and a valence rating for each word. These data are intended to capture subjective verbal-cognitive changes across the intervention period using a standardized and minimally burdensome procedure.
Adherence, tolerability, and safety will be monitored throughout the study. At each session, researchers will record session completion, duration, deviations, and any relevant incidents. Participants will complete a brief checklist assessing comfort, tolerability, ease of use, and any discomfort associated with the assigned procedures. Any adverse events, unusual sensations, interruptions, or reasons for withdrawal will be documented systematically.
Recruitment will be continuous, with sequential enrollment expected over approximately 24 months. All sessions and assessments will be conducted at the Faculty of Psychology, Ibaeta Campus, University of the Basque Country (UPV/EHU). The study is conducted under the supervision of the research team led by Ainara Aranberri Ruiz, and all study procedures will be carried out confidentially and in accordance with applicable ethical requirements.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- This study uses a 2 × 2 factorial randomized controlled design to evaluate the independent and combined effects of stimulation and training. The two intervention factors are stimulation condition (active transcutaneous auricular vagus nerve stimulation [taVNS] vs. sham taVNS) and training condition (active heart rate variability biofeedback [HRV-biofeedback] vs. control training). Participants will be randomly assigned in equal proportions (1:1:1:1) to one of four parallel groups: sham taVNS + control training, sham taVNS + HRV-biofeedback, active taVNS + control training, or active taVNS + HRV-biofeedback. This model allows estimation of the main effects of each factor and their interaction. Assessments will be performed at baseline (Day 1, pre-intervention) and post-intervention (Day 5, after the final session).
| Arm | Type | Receives |
|---|---|---|
| Sham taVNS + HRV-Biofeedback Training | Experimental | Combination Product: LasaiONParticipants assigned to this arm will receive sham taVNS together with active HRV-biofeedback training over 5 consecutive intervention days, with one supervised 60-minute session per day. In each session, participants will sit comfortably in front of a computer. A sham taVNS device will be positioned at the tragus but will not deliver active electrical stimulation, while heart rate variability biofeedback will be provided through an ear sensor connected to the emWave platform. Sessions will include a brief pre-session checklist, fitting of psychophysiological recording equipment (EEG, HRV, EDA/EMG), a short quiet baseline, approximately 10 minutes of slow paced breathing (~6 breaths/min) supported by Coherence Coach, followed by post-session tolerability/comfort ratings. This arm is designed to isolate the effect of active HRV-biofeedback training in the absence of active taVNS. |
| Active taVNS + Control Training | Experimental | Combination Product: LasaiONParticipants assigned to this arm will receive active transcutaneous auricular vagus nerve stimulation (taVNS) combined with control training across five consecutive intervention days, with one supervised 60-minute session per day. During each session, participants will be seated comfortably in front of a computer. Active taVNS will be delivered at the tragus, while the training component will consist of a control condition without the Coherence Coach application, rather than active HRV biofeedback. Sessions will include a brief pre-session checklist, fitting of psychophysiological recording equipment (EEG, HRV, and EDA/EMG), a short resting baseline, and post-session ratings of tolerability and comfort. This arm is intended to isolate the effect of active taVNS in the absence of active HRV biofeedback training. |
| Active taVNS + HRV-Biofeedback Training | Experimental | Combination Product: LasaiONParticipants assigned to this arm will receive the full active LasaiON intervention over 5 consecutive intervention days, with one supervised 60-minute session per day. In each session, participants will sit comfortably in front of a computer while receiving active transcutaneous auricular vagus nerve stimulation (taVNS) at the tragus together with active heart rate variability biofeedback (HRV-biofeedback) breathing training supported by the emWave platform. Sessions will include a brief pre-session checklist, fitting of psychophysiological recording equipment (EEG, HRV, EDA/EMG), a short quiet baseline, delivery of both active intervention components, and post-session tolerability/comfort ratings. This arm is designed to evaluate the combined effect of active taVNS and active HRV-biofeedback training and to determine whether their combination produces greater benefits than either component alone or than the fully control condition. |
| sham taVNS+control training | Sham comparator | Combination Product: LasaiONThis control condition is delivered over 5 consecutive days, with one supervised 60-minute session per day, and is designed to match the active intervention in schedule, setting, and researcher contact without providing the active therapeutic components. Participants attend the sessions in the same standardized format, but the sham taVNS device placed at the tragus does not deliver active electrical stimulation, and the training condition does not include active HRV-biofeedback or the paced-breathing training intended to consolidate a respiratory rhythm of approximately 6 breaths per minute. This condition is intended to control for expectancy, procedural context, and time spent in session while withholding both active taVNS and active HRV-biofeedback training. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LasaiONParticipants 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. | Combination product | Active taVNS + Control Training, Active taVNS + HRV-Biofeedback Training, Sham taVNS + HRV-Biofeedback Training, sham taVNS+control training |
Primary outcome
State anxiety score
Time frame: From baseline (day 1) to post-intervention (day 5)
Change in state anxiety assessed with the State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-State). Scores range from 20 to 80, with higher scores indicating greater anxiety.
Depressive symptom score
Time frame: From baseline (day 1) to post-intervention (day5)
Change in depressive symptoms assessed with the 17-item Hamilton Depression Rating Scale (HAM-D). Scores range from 0 to 52, with higher scores indicating greater depressive symptom severity.
WHO-5 well-being score
Time frame: From baseline (day 1) to post-intervention (day 5)
Change in emotional well-being assessed with the World Health Organization-Five Well-Being Index (WHO-5). Raw scores range from 0 to 25, with higher scores indicating better emotional well-being.
Change in RMSSD
Time frame: from baseline (day 1) to post-intervention (day 5)
Change in heart rate variability assessed by the root mean square of successive differences (RMSSD) using Kubios HRV software. RMSSD reflects beat-to-beat variability in heart rate and is reported in milliseconds (ms). Higher values indicate greater vagally mediated heart rate variability, whereas lower values indicate lower vagally mediated heart rate variability.
Change in skin conductance level
Time frame: From baseline (day 1) to post-intervention (day 5)
Change in physiological arousal assessed by skin conductance level, measured in microsiemens (µS). Higher values indicate greater sympathetic arousal.
Change in startle response amplitude
Time frame: From baseline (day 1) to post-intervention (day 5)
Change in physiological reactivity assessed by the peak amplitude of the acoustic startle eyeblink response, recorded from the orbicularis oculi muscle using electromyography (EMG). Startle amplitude will be defined as the peak EMG response occurring within 20 to 150 milliseconds after startle probe onset relative to the mean 50-millisecond pre-probe baseline. Amplitude will be reported in microvolts (µV), with higher values indicating greater physiological reactivity.
Change in frontal midline theta band power at Fz
Time frame: from baseline (day 1) to post-intervention (day 5)
Change in frontal midline theta band power at Fz, recorded using the 8-channel Unicorn Hybrid Black electroencephalography (EEG) system. EEG data will be acquired at 250 Hz per channel and analyzed as absolute spectral power in the theta frequency band (4-8 Hz). Theta band power will be reported in microvolts squared per hertz (µV²/Hz). Higher values indicate greater frontal midline theta band power.
Change in frequency of intrusive-thought-related lexical occurrences
Time frame: from baseline (day 1) to post-intervention (day 5)
Change in intrusive thoughts assessed by counting prespecified intrusive-thought-related lexical occurrences in written self-reports using IRaMuTeQ text analysis software. Frequency will be reported as the number of intrusive-thought-related lexical occurrences per written self-report. A value of 0 indicates no intrusive-thought-related lexical occurrences, and higher values indicate greater intrusive-thought-related lexical content.
Change in SDNN
Time frame: From baseline (day 1) to post-intervention (day 5)
Change in heart rate variability assessed by the standard deviation of normal-to-normal RR intervals (SDNN) using Kubios HRV software. SDNN reflects overall heart rate variability, including both short-term and longer-term components, and is reported in milliseconds (ms). Higher values indicate greater overall heart rate variability, whereas lower values indicate lower overall heart rate variability.
Change in high-frequency power
Time frame: From baseline (day 1) to post-intervention (day 5)
Change in heart rate variability assessed by high-frequency (HF) power using Kubios HRV software. HF power reflects high-frequency heart rate variability and will be reported as absolute power in milliseconds squared (ms²). Higher values generally indicate greater vagally mediated, parasympathetic modulation of heart rate variability.
Change in low-frequency power
Time frame: From baseline (day 1) to post-intervention (day 5)
Change in heart rate variability assessed by low-frequency (LF) power using Kubios HRV software. LF power reflects low-frequency heart rate variability and will be reported as absolute power in milliseconds squared (ms²). Higher values indicate greater low-frequency heart rate variability.
Change in LF/HF ratio
Time frame: From baseline (day 1) to post-intervention (day 5)
Change in heart rate variability assessed by the ratio of low-frequency to high-frequency power (LF/HF) using Kubios HRV software. The LF/HF ratio will be reported as a unitless ratio. Higher values indicate a higher ratio of low-frequency to high-frequency power.
Change in PNS index
Time frame: From baseline (day 1) to post-intervention (day 5)
Change in autonomic function, assessed using the parasympathetic nervous system (PNS) index obtained from Kubios HRV software. In Kubios, a value of 0 reflects autonomic activity comparable to the normative population mean; positive values indicate higher parasympathetic activity, whereas negative values indicate lower parasympathetic activity.
Change in SNS index
Time frame: From baseline (day 1) to post-intervention (day 5
Change in autonomic function assessed by the sympathetic nervous system (SNS) index using Kubios HRV software. In Kubios, a value of 0 indicates values comparable to the normal population average; positive values indicate above-average sympathetic activity, and negative values indicate below-average sympathetic activity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 38963749Zhang Y, Lin P, Wang R, Zhou J, Xu X, Jiang W, Pu X, Ge S. Insula-Medial Prefrontal Cortex Functional Connectivity Modulated by Transcutaneous Auricular Vagus Nerve Stimulation: An fMRI Study. IEEE J Biomed Health Inform. 2024 Oct;28(10):5962-5970. doi: 10.1109/JBHI.2024.3423019. Epub 2024 Oct 3.
- Background: PubMed 34155631Dormal V, Vermeulen N, Mejias S. Is heart rate variability biofeedback useful in children and adolescents? A systematic review. J Child Psychol Psychiatry. 2021 Dec;62(12):1379-1390. doi: 10.1111/jcpp.13463. Epub 2021 Jun 21.
- Background: PubMed 38042286Tian QQ, Cheng C, Yin ZX, Yuan YY, Wang C, Zeng X, Sun JB, Yang Q, Yang XJ, Qin W. Combined transcutaneous auricular vagus stimulation (taVNS) with 0.1Hz slow breathing enhances insomnia treatment efficacy: A pilot study. Brain Stimul. 2024 Jan-Feb;17(1):4-6. doi: 10.1016/j.brs.2023.11.015. Epub 2023 Nov 30. No abstract available.
- Background: PubMed 22568773Napadow V, Edwards RR, Cahalan CM, Mensing G, Greenbaum S, Valovska A, Li A, Kim J, Maeda Y, Park K, Wasan AD. Evoked pain analgesia in chronic pelvic pain patients using respiratory-gated auricular vagal afferent nerve stimulation. Pain Med. 2012 Jun;13(6):777-89. doi: 10.1111/j.1526-4637.2012.01385.x. Epub 2012 May 8.
- Background: PubMed 32358769McAllister-Williams RH, Sousa S, Kumar A, Greco T, Bunker MT, Aaronson ST, Conway CR, Rush AJ. The effects of vagus nerve stimulation on the course and outcomes of patients with bipolar disorder in a treatment-resistant depressive episode: a 5-year prospective registry. Int J Bipolar Disord. 2020 May 2;8(1):13. doi: 10.1186/s40345-020-0178-4.
- Background: PubMed 36543841Kim AY, Marduy A, de Melo PS, Gianlorenco AC, Kim CK, Choi H, Song JJ, Fregni F. Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Sci Rep. 2022 Dec 21;12(1):22055. doi: 10.1038/s41598-022-25864-1.
- Background: PubMed 29946920Thabrew H, Ruppeldt P, Sollers JJ 3rd. Systematic Review of Biofeedback Interventions for Addressing Anxiety and Depression in Children and Adolescents with Long-Term Physical Conditions. Appl Psychophysiol Biofeedback. 2018 Sep;43(3):179-192. doi: 10.1007/s10484-018-9399-z.
- Background: PubMed 28478782Goessl VC, Curtiss JE, Hofmann SG. The effect of heart rate variability biofeedback training on stress and anxiety: a meta-analysis. Psychol Med. 2017 Nov;47(15):2578-2586. doi: 10.1017/S0033291717001003. Epub 2017 May 8.
- Background: PubMed 34365067Garcia RG, Cohen JE, Stanford AD, Gabriel A, Stowell J, Aizley H, Barbieri R, Gitlin D, Napadow V, Goldstein JM. Respiratory-gated auricular vagal afferent nerve stimulation (RAVANS) modulates brain response to stress in major depression. J Psychiatr Res. 2021 Oct;142:188-197. doi: 10.1016/j.jpsychires.2021.07.048. Epub 2021 Aug 2.
- Background: PubMed 25963932Fang J, Rong P, Hong Y, Fan Y, Liu J, Wang H, Zhang G, Chen X, Shi S, Wang L, Liu R, Hwang J, Li Z, Tao J, Wang Y, Zhu B, Kong J. Transcutaneous Vagus Nerve Stimulation Modulates Default Mode Network in Major Depressive Disorder. Biol Psychiatry. 2016 Feb 15;79(4):266-73. doi: 10.1016/j.biopsych.2015.03.025. Epub 2015 Apr 2.
- Background: PubMed 37016184Umac EH, Semerci R. Effect of Biofeedback-Based Interventions on the Psychological Outcomes of Pediatric Populations: A Systematic Review and Meta-analysis. Appl Psychophysiol Biofeedback. 2023 Sep;48(3):299-310. doi: 10.1007/s10484-023-09583-5. Epub 2023 Apr 4.
- Background: PubMed 41261293Darabi MD, Silber SP, Slotkin R, Peechatka AL. Biofeedback-based Digital Games and Well-being in Childhood: A Systematic Review. Res Child Adolesc Psychopathol. 2025 Dec;53(12):2115-2130. doi: 10.1007/s10802-025-01387-x. Epub 2025 Nov 20.
- Individual participant dataSharing planned: No. Data will be anonymized and will not be shared with third parties. The dataset will be registered at the University of the Basque Country (UPV/EHU) under the following data-processing record, in accordance with the EU General Data Protection Regulation (GDPR; Regulation (EU) 2016/679): data-processing code TI0741-1471 ; name of the data-processing activity: LasaiON
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LasaiON in people with Adult, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ainara Aranberri Ruiz, Ph.D. (943018311, ainara.aranberri@ehu.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State anxiety score (time frame: From baseline (day 1) to post-intervention (day 5)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07498881, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.