Depression - Major Depressive DisorderAdd-VagusNCT07844733
Slow-Paced Breathing and Electrical Vagus Nerve Stimulation as Add-on Treatments for Depression
A study testing Slow-Paced Breathing, Transcutaneous Auricular Vagus Nerve Stimulation (tVNS) and Treatment as Usual (TAU) in people with Depression - Major Depressive Disorder, run by Elisabeth Balint at 1 site in Switzerland.
Trial summary
Depression is a common mental health condition, and standard psychiatric therapies do not always lead to satisfactory recovery. As a result, there is an urgent need for effective, complementary treatments. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- Slow-Paced Breathing, Transcutaneous Auricular Vagus Nerve Stimulation (tVNS) and Treatment as Usual (TAU)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2026to Sep 2030
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Inpatient psychiatric admission at Privatklinik Meiringen
- Clinical primary diagnosis of at least a moderate depressive episode
- Beck Depression Inventory-II (BDI-II) score of at least 20 at admission
- Age between 18 and 60 years
- Written informed consent prior to study participation
- Ability to understand the study procedures and give informed consent
Who cannot join
- Active substance use disorder / addiction
- Current psychosis
- Bipolar disorder
- Borderline personality disorder
- Current malignancy
- Multiple sclerosis
Show all 10Show fewer
- Presence of a cardiac pacemaker
- Known or confirmed pregnancy
- Body Mass Index (BMI) greater than 35 kg/m²
- Current treatment with, or planned administration during the hospital stay of, ketamine or electroconvulsive therapy (ECT)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Privatklinik Meiringen
Meiringen, 3860
Elisabeth M Balint, PD Dr. med., +41339728246, elisabeth.balint@privatklinik-meiringen.ch
About this study
Official title: Add-on Therapy of Depression Using Vagus Nerve Stimulation
Depression is a common mental health condition, and standard psychiatric therapies do not always lead to satisfactory recovery. As a result, there is an urgent need for effective, complementary treatments.
The vagus nerve is the main component of the parasympathetic nervous system, which regulates bodily rest and calms inflammatory responses. In clinical depression, vagus nerve activity is often reduced, and low-grade inflammation is frequently observed. While electrical stimulation of the vagus nerve via surgically implanted devices has been shown to reduce depressive symptoms, its invasive nature carries risks. Non-invasive alternatives-such as slow-paced breathing exercises or gentle transcutaneous electrical stimulation at the outer ear-offer promising ways to stimulate this nerve safely without surgery.
Read more
The main purpose of this clinical study is to evaluate whether slow-paced breathing is an effective add-on therapy to reduce depressive symptoms in hospitalized patients compared to standard multimodal psychiatric treatment. Additionally, the study investigates whether the effects of slow-paced breathing are comparable to transcutaneous auricular vagus nerve stimulation (tVNS) and whether they differ from a sham (placebo) stimulation.
A total of 160 adult inpatients with at least a moderate depressive episode will be randomly assigned to one of four groups during their hospital stay:
Group 1 (Slow-Paced Breathing): Participants practice a guided, slow-paced breathing technique (inhaling for 4 seconds, exhaling for 6 seconds) for 20 minutes, 3 times daily, 5 days per week over 4 weeks.
Group 2 (Electrical Vagus Nerve Stimulation): Participants receive non-invasive electrical stimulation to the outer ear canal using a certified medical device (tVNS) for 20 minutes, 3 times daily, 5 days per week over 4 weeks.
Group 3 (Sham Stimulation): Participants receive identical-looking electrical stimulation applied to the earlobe (an area lacking vagal nerve fibers) on the same schedule, serving as an active control. Participants do not know whether they receive active or sham stimulation.
Group 4 (Treatment as Usual): Participants receive the standard multimodal inpatient psychiatric treatment program alone, alongside daily logging of relaxation and mindfulness activities.
All participants continue to receive standard psychiatric care. Depressive symptoms are assessed using the Beck Depression Inventory-II (BDI-II) and the Hamilton Depression Rating Scale. In addition, heart rate variability (HRV) via a 24-hour recording and blood inflammatory markers (such as IL-6 and CRP) are measured before and after the 4-week intervention period to explore the physiological mechanisms of vagus activation. A follow-up questionnaire is completed after 3 months to assess long-term outcomes.
- Conditions
- Depression - Major Depressive Disorder
- Being tested
- Slow-Paced Breathing, Transcutaneous Auricular Vagus Nerve Stimulation (tVNS), Sham Auricular Electrical Stimulation, Treatment as Usual (TAU)
- Keywords
- Vagus Nerve Stimulation, Slow-Paced Breathing, Transcutaneous Vagus Nerve Stimulation, tVNS, Heart Rate Variability, HRV, Inpatient Psychiatry, Inflammation, Non-invasive Neuromodulation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow-Paced BreathingBehavioural
Guided slow-paced breathing technique with prolonged exhalation (4 seconds inhalation, 6 seconds exhalation, resulting in 6 breaths per minute) to stimulate the vagus nerve. Conducted for 20 minutes, 3 times daily, 5 days per week over a period of 4 weeks in a seated position, accompanied by daily protocol logging. Administered in addition to standard inpatient psychiatric care.
Transcutaneous Auricular Vagus Nerve Stimulation (tVNS)Device
Electrical nerve stimulation using a CE-certified class IIa medical device (tVNS® by tVNS Technologies GmbH). Stimulation is applied via custom ear electrodes to the cymba conchae of the left outer ear canal to transcutaneously activate vagal afferents. Parameters: 25 Hz frequency, 250 µs pulse duration, 28 s ON / 32 s OFF cycle, intensity adjusted individually between 0.1 and 5.0 mA below pain threshold. Administered for 20 minutes, 3 times daily, 5 days per week over 4 weeks as an add-on to standard inpatient care.
Sham Auricular Electrical StimulationDevice
Sham sensory control using identical stimulation parameters (25 Hz, 250 µs pulses, 28 s ON / 32 s OFF) and device setup as active tVNS, but the stimulation electrode is attached to the left earlobe, a region devoid of vagal innervation. Conducted for 20 minutes, 3 times daily, 5 days per week for 4 weeks in addition to standard inpatient care.
Standard multimodal inpatient psychiatric and psychotherapeutic treatment program including medication, psychotherapy, and clinical ward routine, accompanied by daily logging of relaxation exercises.
| Study group | Role | What they receive |
|---|---|---|
| Slow-Paced Breathing | Experimental | Participants perform a guided, device-free slow-paced breathing technique with prolonged exhalation (inhalation for 4 seconds, exhalation for 6 seconds) to stimulate the vagus nerve. The intervention is practiced for 20 minutes, 3 times daily (morning, afternoon, evening), on 5 days per week over a period of 4 weeks. Participants sit alone in a room and complete a daily protocol logging session duration, breathing frequency, and side effects. This intervention is administered in addition to standard inpatient psychiatric treatment (Treatment as Usual). Receives: Behavioral: Slow-Paced Breathing |
| Transcutaneous Auricular Vagus Nerve Stimulation (tVNS) | Active comparator | Participants receive non-invasive transcutaneous electrical stimulation of the auricular branch of the vagus nerve via a CE-certified ear electrode (tVNS device) placed in the cymba conchae of the left ear. Stimulation is applied for 20 minutes, 3 times daily, on 5 days per week over 4 weeks. Stimulation parameters include 25 Hz frequency, 250 µs pulse width, with alternating 28 s ON and 32 s OFF cycles at individually adjusted sensory thresholds (0.1-5.0 mA). Administered as an add-on to standard inpatient psychiatric treatment. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation (tVNS) |
| Sham Auricular Stimulation | Sham comparator | Participants receive identical-looking electrical stimulation applied to the left earlobe, an area free of cutaneous vagal innervation, serving as an active sensory placebo control. The session schedule (20 minutes, 3 times daily, 5 days per week for 4 weeks) and technical stimulus parameters match the active tVNS arm. Participants are blinded regarding whether they receive active or sham stimulation. Administered in addition to standard inpatient psychiatric treatment. Receives: Device: Sham Auricular Electrical Stimulation |
| Treatment as Usual (TAU) | Other | Participants receive the standard multimodal inpatient psychiatric and psychotherapeutic treatment program alone, including medical visits, psychopharmacotherapy, individual and group psychotherapy, and standard ward activities. To mitigate nocebo effects, participants are instructed to engage in standard relaxation/mindfulness elements offered on the ward and keep a daily log of time spent on relaxation exercises. No experimental breathing or electrical nerve stimulation is applied. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Beck Depression Inventory-II (BDI-II) Score at Week 4
The Beck Depression Inventory-II (BDI-II) is a 21-item self-report instrument used to measure the severity of depressive symptoms. Each item is scored on a 4-point scale ranging from 0 to 3, yielding a total score from 0 to 63 points. Higher scores indicate greater severity of depression (0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression). The change in the total score from baseline (Week 0) to completion of the 4-week intervention period will be analyzed.
Measured: Baseline (Week 0) and post-intervention (Week 4)
Secondary outcomes (6)
Change From Baseline in Hamilton Depression Rating Scale (HAMD) Score at Week 4
The Hamilton Depression Rating Scale (HAMD) is a clinician-rated assessment tool used to quantify the severity of depressive symptoms in patients diagnosed with depression. The scale rates various depressive symptoms (including mood, feelings of guilt, suicide ideation, insomnia, anxiety, and somatic symptoms). Higher total scores reflect greater symptom severity. The change from baseline (Week 0) to completion of the 4-week intervention period will be analyzed.
Measured: Baseline (Week 0) and Week 4 (post-intervention)
Change From Baseline in Brief Symptom Checklist (BSCL) Score at Week 4 and 16
The Brief Symptom Checklist (BSCL) is a validated self-report questionnaire assessing current subjective psychological distress and psychiatric symptom burden across multiple dimensions (e.g., somatization, depression, anxiety). Items are rated on a 5-point Likert scale (0 = not at all, to 4 = extremely), with higher scores reflecting higher levels of subjective psychological distress. Changes from baseline to Week 4 and the 3-month follow-up (Week 16) will be evaluated.
Measured: Baseline (Week 0), Week 4 (post-intervention), and Week 16 (3-month follow-up)
Change From Baseline in General Self-Efficacy Scale (SWE) Score at Week 4 and Week 16
The General Self-Efficacy Scale (SWE / Selbstwirksamkeitserwartung) is a self-report instrument assessing optimistic self-beliefs and confidence in coping with a variety of difficult demands and life challenges. Higher total scores indicate a greater perceived sense of personal self-efficacy and competence. Changes from baseline to Week 4 and the 3-month follow-up (Week 16) will be evaluated.
Measured: Baseline (Week 0), Week 4 (post-intervention), and Week 16 (3-month follow-up)
Change From Baseline in Heart Rate Variability (HRV) Parameters at Week 4
Heart rate variability will be measured using 24-hour ambulatory ECG recordings analyzed via Kubios HRV software. Evaluated autonomic regulation parameters include time-domain metrics: standard deviation of normal-to-normal intervals (SDNN, in ms) and root mean square of successive differences (RMSSD, in ms); and frequency-domain metrics: low-frequency power (LF, in ms²), high-frequency power (HF, in ms²), and total power (in ms²). Higher RMSSD and HF power reflect increased parasympathetic (vagal) tone. Change from baseline to post-intervention (Week 4) will be evaluated.
Measured: Baseline (Week 0) and Week 4 (post-intervention)
Change From Baseline in Serum Inflammatory Markers at Week 4
Fasting serum venous blood samples will be analyzed using high-sensitivity multiplex assays to evaluate pro- and anti-inflammatory cytokine concentrations and systemic inflammation. Specific biomarkers quantified include high-sensitivity C-reactive protein (hsCRP, in mg/L), interleukin-6 (IL-6, in pg/mL), interleukin-1 (IL-1, in pg/mL), interleukin-4 (IL-4, in pg/mL), and tumor necrosis factor-alpha (TNF-alpha, in pg/mL). Changes in biomarker concentrations from baseline to Week 4 will be assessed.
Measured: Baseline (Week 0) and Week 4 (post-intervention)
Long-term Change in Beck Depression Inventory-II (BDI-II) Score at 3-Month Follow-Up
Assessment of the sustained treatment effect on depressive symptom severity using the 21-item BDI-II self-report total score (range 0-63, higher scores indicating more severe depression) at the 3-month follow-up compared to post-intervention (Week 4) and baseline (Week 0).
Measured: Week 16 (3 months post-intervention follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elisabeth Balint
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elisabeth Balint, Privatklinik Meiringen
- Investigators
- Elisabeth M Balint, PD Dr. med., Principal investigator, Privatklinik Meiringen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844733
- Sponsor's protocol ID
- 2026-01402
- Acronym
- Add-Vagus
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be made available upon reasonable request to other qualified scientific researchers. Requests must include a methodologically sound research proposal and will be evaluated by the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Add-on Therapy of Depression Using Vagus Nerve Stimulation
- ClinicalTrials.gov ID
- NCT07844733
- Acronym / sponsor ID
- Add-Vagus / 2026-01402
- Conditions
- Depression - Major Depressive Disorder
- Keywords
- Vagus Nerve Stimulation, Slow-Paced Breathing, Transcutaneous Vagus Nerve Stimulation, tVNS, Heart Rate Variability, HRV, Inpatient Psychiatry, Inflammation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Elisabeth BalintUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 28 Sep 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.
Depression is a common mental health condition, and standard psychiatric therapies do not always lead to satisfactory recovery. As a result, there is an urgent need for effective, complementary treatments.
The vagus nerve is the main component of the parasympathetic nervous system, which regulates bodily rest and calms inflammatory responses. In clinical depression, vagus nerve activity is often reduced, and low-grade inflammation is frequently observed. While electrical stimulation of the vagus nerve via surgically implanted devices has been shown to reduce depressive symptoms, its invasive nature carries risks. Non-invasive alternatives-such as slow-paced breathing exercises or gentle transcutaneous electrical stimulation at the outer ear-offer promising ways to stimulate this nerve safely without surgery.
The main purpose of this clinical study is to evaluate whether slow-paced breathing is an effective add-on therapy to reduce depressive symptoms in hospitalized patients compared to standard multimodal psychiatric treatment. Additionally, the study investigates whether the effects of slow-paced breathing are comparable to transcutaneous auricular vagus nerve stimulation (tVNS) and whether they differ from a sham (placebo) stimulation.
A total of 160 adult inpatients with at least a moderate depressive episode will be randomly assigned to one of four groups during their hospital stay:
Group 1 (Slow-Paced Breathing): Participants practice a guided, slow-paced breathing technique (inhaling for 4 seconds, exhaling for 6 seconds) for 20 minutes, 3 times daily, 5 days per week over 4 weeks.
Group 2 (Electrical Vagus Nerve Stimulation): Participants receive non-invasive electrical stimulation to the outer ear canal using a certified medical device (tVNS) for 20 minutes, 3 times daily, 5 days per week over 4 weeks.
Group 3 (Sham Stimulation): Participants receive identical-looking electrical stimulation applied to the earlobe (an area lacking vagal nerve fibers) on the same schedule, serving as an active control. Participants do not know whether they receive active or sham stimulation.
Group 4 (Treatment as Usual): Participants receive the standard multimodal inpatient psychiatric treatment program alone, alongside daily logging of relaxation and mindfulness activities.
All participants continue to receive standard psychiatric care. Depressive symptoms are assessed using the Beck Depression Inventory-II (BDI-II) and the Hamilton Depression Rating Scale. In addition, heart rate variability (HRV) via a 24-hour recording and blood inflammatory markers (such as IL-6 and CRP) are measured before and after the 4-week intervention period to explore the physiological mechanisms of vagus activation. A follow-up questionnaire is completed after 3 months to assess long-term outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Slow-Paced Breathing | Experimental | Behavioral: Slow-Paced BreathingParticipants perform a guided, device-free slow-paced breathing technique with prolonged exhalation (inhalation for 4 seconds, exhalation for 6 seconds) to stimulate the vagus nerve. The intervention is practiced for 20 minutes, 3 times daily (morning, afternoon, evening), on 5 days per week over a period of 4 weeks. Participants sit alone in a room and complete a daily protocol logging session duration, breathing frequency, and side effects. This intervention is administered in addition to standard inpatient psychiatric treatment (Treatment as Usual). |
| Transcutaneous Auricular Vagus Nerve Stimulation (tVNS) | Active comparator | Device: Transcutaneous Auricular Vagus Nerve Stimulation (tVNS)Participants receive non-invasive transcutaneous electrical stimulation of the auricular branch of the vagus nerve via a CE-certified ear electrode (tVNS device) placed in the cymba conchae of the left ear. Stimulation is applied for 20 minutes, 3 times daily, on 5 days per week over 4 weeks. Stimulation parameters include 25 Hz frequency, 250 µs pulse width, with alternating 28 s ON and 32 s OFF cycles at individually adjusted sensory thresholds (0.1-5.0 mA). Administered as an add-on to standard inpatient psychiatric treatment. |
| Sham Auricular Stimulation | Sham comparator | Device: Sham Auricular Electrical StimulationParticipants receive identical-looking electrical stimulation applied to the left earlobe, an area free of cutaneous vagal innervation, serving as an active sensory placebo control. The session schedule (20 minutes, 3 times daily, 5 days per week for 4 weeks) and technical stimulus parameters match the active tVNS arm. Participants are blinded regarding whether they receive active or sham stimulation. Administered in addition to standard inpatient psychiatric treatment. |
| Treatment as Usual (TAU) | Other | Other: Treatment as Usual (TAU)Participants receive the standard multimodal inpatient psychiatric and psychotherapeutic treatment program alone, including medical visits, psychopharmacotherapy, individual and group psychotherapy, and standard ward activities. To mitigate nocebo effects, participants are instructed to engage in standard relaxation/mindfulness elements offered on the ward and keep a daily log of time spent on relaxation exercises. No experimental breathing or electrical nerve stimulation is applied. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Inpatient psychiatric admission at Privatklinik Meiringen
- Clinical primary diagnosis of at least a moderate depressive episode
- Beck Depression Inventory-II (BDI-II) score of at least 20 at admission
- Age between 18 and 60 years
- Written informed consent prior to study participation
Key exclusion criteria (10 listed)
- Active substance use disorder / addiction
- Current psychosis
- Bipolar disorder
- Borderline personality disorder
- Current malignancy
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 |
|---|---|---|
| Slow-Paced BreathingGuided slow-paced breathing technique with prolonged exhalation (4 seconds inhalation, 6 seconds exhalation, resulting in 6 breaths per minute) to stimulate the vagus nerve. Conducted for 20 minutes, 3 times daily, 5 days per week over a period of 4 weeks in a seated position, accompanied by daily protocol logging. Administered in addition to standard inpatient psychiatric care. | Behavioural | Slow-Paced Breathing |
| Transcutaneous Auricular Vagus Nerve Stimulation (tVNS)Electrical nerve stimulation using a CE-certified class IIa medical device (tVNS® by tVNS Technologies GmbH). Stimulation is applied via custom ear electrodes to the cymba conchae of the left outer ear canal to transcutaneously activate vagal afferents. Parameters: 25 Hz frequency, 250 µs pulse duration, 28 s ON / 32 s OFF cycle, intensity adjusted individually between 0.1 and 5.0 mA below pain threshold. Administered for 20 minutes, 3 times daily, 5 days per week over 4 weeks as an add-on to standard inpatient care. | Device | Transcutaneous Auricular Vagus Nerve Stimulation (tVNS) |
| Sham Auricular Electrical StimulationSham sensory control using identical stimulation parameters (25 Hz, 250 µs pulses, 28 s ON / 32 s OFF) and device setup as active tVNS, but the stimulation electrode is attached to the left earlobe, a region devoid of vagal innervation. Conducted for 20 minutes, 3 times daily, 5 days per week for 4 weeks in addition to standard inpatient care. | Device | Sham Auricular Stimulation |
| Treatment as Usual (TAU)Standard multimodal inpatient psychiatric and psychotherapeutic treatment program including medication, psychotherapy, and clinical ward routine, accompanied by daily logging of relaxation exercises. | Other | Treatment as Usual (TAU) |
Primary outcome
Change From Baseline in Beck Depression Inventory-II (BDI-II) Score at Week 4
Time frame: Baseline (Week 0) and post-intervention (Week 4)
The Beck Depression Inventory-II (BDI-II) is a 21-item self-report instrument used to measure the severity of depressive symptoms. Each item is scored on a 4-point scale ranging from 0 to 3, yielding a total score from 0 to 63 points. Higher scores indicate greater severity of depression (0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression). The change in the total score from baseline (Week 0) to completion of the 4-week intervention period will be analyzed.
6 secondary outcomes
Change From Baseline in Hamilton Depression Rating Scale (HAMD) Score at Week 4
Time frame: Baseline (Week 0) and Week 4 (post-intervention)
Change From Baseline in Brief Symptom Checklist (BSCL) Score at Week 4 and 16
Time frame: Baseline (Week 0), Week 4 (post-intervention), and Week 16 (3-month follow-up)
Change From Baseline in General Self-Efficacy Scale (SWE) Score at Week 4 and Week 16
Time frame: Baseline (Week 0), Week 4 (post-intervention), and Week 16 (3-month follow-up)
Change From Baseline in Heart Rate Variability (HRV) Parameters at Week 4
Time frame: Baseline (Week 0) and Week 4 (post-intervention)
Change From Baseline in Serum Inflammatory Markers at Week 4
Time frame: Baseline (Week 0) and Week 4 (post-intervention)
Long-term Change in Beck Depression Inventory-II (BDI-II) Score at 3-Month Follow-Up
Time frame: Week 16 (3 months post-intervention follow-up)
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 2 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be made available upon reasonable request to other qualified scientific researchers. Requests must include a methodologically sound research proposal and will be evaluated by the principal investigator.
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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.
Elisabeth M Balint, PD Dr. med. principal investigator
Privatklinik Meiringen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow-Paced Breathing, Transcutaneous Auricular Vagus Nerve Stimulation (tVNS) and Treatment as Usual (TAU) in people with Depression - Major Depressive Disorder, run by Elisabeth Balint at 1 site in Switzerland.
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 6 inclusion and 10 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 2 Oct 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 Switzerland. 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 Elisabeth M Balint, PD Dr. med. (+41339728246, elisabeth.balint@privatklinik-meiringen.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Beck Depression Inventory-II (BDI-II) Score at Week 4 (time frame: Baseline (Week 0) and post-intervention (Week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2026.