Ear-Zap therapy could lift mood in heart attack survivors
NCT ID NCT07454070
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a non-invasive device that gently stimulates a nerve in the ear to see if it can reduce depression symptoms in people who have had a heart attack or related heart problem and a stent placed. About 120 adults will use the device at home for 8 weeks, and their mood will be tracked for another 8 weeks. Half will get the real stimulation, and half will get a fake version, so researchers can see if it truly helps.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years * Meeting the diagnostic criteria for ACS * 14 days to 12 months after successful PCI, with stable vital signs * Meeting the diagnostic criteria for depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) * HAMD-17 score ≥7 and \<24 (mild-to-moderate depression), with HAMA score \<HAMD score; * Refusal of psychiatric consultation, antidepressant medication, or psychological therapy by the patient or their legal representative after full informed consent * Voluntary participation in the study and signing of the informed consent form Exclusion Criteria: * Severe heart failure (New York Heart Association \[NYHA\] class ≥III) * Uncontrolled hypertension (systolic blood pressure ≥180 mmHg and diastolic blood pressure ≥110 mmHg) * Electrocardiographic abnormalities (first-degree atrioventricular block with PR interval ≥0.20 s, second-degree type II or third-degree atrioventricular block at any time, 24-hour average heart rate ≤50 beats per minute, RR interval ≥3 s) or a history of syncope unrelated to the current ACS * Dialysis-dependent patients * Previous renal sympathetic denervation or vagal ganglion ablation * Expected survival time \<4 months * Pre-PCI diagnosis of severe mental illnesses, including schizophrenia, severe intellectual disability, or substance abuse * Current use of antipsychotic medications * High suicide risk * Pregnant or lactating women * Left ear diseases, acute exacerbation of asthma or chronic obstructive pulmonary disease, or other conditions precluding taVNS treatment * Implanted cardiac pacemaker, implantable cardioverter-defibrillator (ICD), or other implantable stimulators (e.g., vagus nerve stimulator, deep brain stimulator)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tang-Du Hospital,Department of Cardiology
RECRUITINGXi'an, Shaanxi, 710038, China
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