Tragus stimulation for Heart Failure

Phase-Based Estimates
1
Effectiveness
1
Safety
OUHSC, Oklahoma City, OK
+1 More
Tragus stimulation - Device
Eligibility
18+
All Sexes
Eligible conditions
Heart Failure

Study Summary

Low Level Tragus Stimulation in Acute Decompensated Heart Failure

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Eligible Conditions

  • Heart Failure
  • Acute Decompensated Heart Failure (ADHF)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Tragus stimulation will improve 3 primary outcomes in patients with Heart Failure. Measurement will happen over the course of During the hospitalization(baseline,day 1, day 2, day 3 and day 4).

Day 4
Change in CRP levels
Change in Interleukin (IL) levels
Change in TNF-alpha levels

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
Tragus Stimulation

This trial requires 80 total participants across 2 different treatment groups

This trial involves 2 different treatments. Tragus Stimulation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Tragus Stimulation
Device
In this group patients will receive tragus stimulation for 8 hours per day during hospital stay.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during the hospitalization(baseline,day 1, day 2, day 3 and day 4)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly during the hospitalization(baseline,day 1, day 2, day 3 and day 4) for reporting.

Closest Location

OUHSC - Oklahoma City, OK

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients admitted with ADHF will undergo echocardiography which is considered standard of care. If estimated LVEF is 40% patients will be enrolled in the study.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for heart failure?

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There is no convincing evidence that specific treatments are superior to other treatments in improving short-term outcomes in heart failure. Combinations of therapies may increase short-term mortality, so treatment in people with heart failure should be individualized.

Unverified Answer

Can heart failure be cured?

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The benefits of exercise in heart failure patients may be overestimated by the physicians and patients if the underlying disease continues. Heart failure is the result of a disease process that is more complex and less understood than we have thought previously. If heart failure patients are not offered proper medical treatment that is based on a good understanding of the disease, and in accordance with the benefits of exercise (as they have been shown by randomized controlled trials) and the negative side-effects of exercise, many people will continue to be disabled due to heart failure, and they will continue to live with a limited life expectancy.

Unverified Answer

What are the signs of heart failure?

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Shortness of breath is an early sign of heart failure. Other early signs of heart failure include a rapid heart rate, shortness of breath with exertion, ankle swelling and swelling of the veins in the legs. Shortness of breath that improves with rest, and that worsens with exertion is an early sign of heart failure.

Unverified Answer

How many people get heart failure a year in the United States?

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Using a three-time-series cross-sectional design, this analysis can provide unbiased, comprehensive estimates of the prevalence, natural history, age-specific incidence, and gender-specific incidence of hospitalizations for heart failure in the US population. The prevalence estimate is lower and the incidence rate higher than previously estimated.

Unverified Answer

What causes heart failure?

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Although most HF related factors are modifiable, people with left sided HF are unlikely to be able to adhere to the lifestyle modifications required to improve prognosis. In right sided HF, patients were unlikely to adhere to standard therapies unless they had other concomitant cardiovascular disease. Lifestyle modification may be more significant in the management of HF with the left sided heart.

Unverified Answer

What is heart failure?

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In patients with heart failure, the most common cause of death is heart failure. The condition of failing heart occurs because the heart is not able to pump blood efficiently, and also because too few heart cells are capable of producing enough oxygen-rich blood. These events lead to a decrease in cardiac output which in turn causes congestion of the veins and arteries. This is called fluid overload, which is a key process in the progression of heart failure.

Unverified Answer

What are the latest developments in tragus stimulation for therapeutic use?

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Tragus stimulation is a promising therapy for the treatment of cardiac and neurological dysfunctions, which may be treated with a special electrode or with implantable devices. It is a well tolerated and effective treatment method and seems useful as a therapeutic option for patients with various diagnoses. Further research is needed to develop the treatment into a usable clinical tool.

Unverified Answer

What does tragus stimulation usually treat?

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TS was found to produce no significant improvement in subjective quality of life. TS was associated with improvement of some of the objective clinical indicators but these changes were relatively small. The only clinical parameter of any note was a significant improvement in resting heart rate. TS was also associated with a small increase in HRV. In a recent study, findings are consistent with those from previous trials that TS has not yielded the gains expected from evidence-based medicine.

Unverified Answer

How does tragus stimulation work?

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Tragus stimulation is safer than tragus recession. It is suggested that in patients with tragus stimulation the upper eyelids must be completely covered, and in patients that have only the lower eyelids covered, the upper eyelid must be opened and closed carefully several times per second.

Unverified Answer

Who should consider clinical trials for heart failure?

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The majority of patients taking medications for treatment of chronic HF, were satisfied with their HF care but did not believe any of the available clinical trials were relevant to their HF treatment. Results from a recent clinical trial has highlighted the need for a greater focus on patient education and understanding regarding the importance of HF clinical trials.

Unverified Answer

Does heart failure run in families?

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Significant associations between family members with HF and common risk alleles (e.g. MYH7, SERCA2a) were identified. Results from a recent clinical trial, together with those of previous studies, implicate a familial basis for this common and significant clinical phenotype.

Unverified Answer

Have there been any new discoveries for treating heart failure?

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Many of the treatments that are used to treat heart failure are already well studied. However, there are new ways of treating heart failure and with that it should be possible to prevent more heart failure in the first place.

Unverified Answer
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