RightFit
Not yet recruitingPhase 1 / Phase 2

Neuromodulation in Patients With Pulmonary Arterial Hypertension

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks
  • Procedures mentioned: Blood draws, Questionnaires, Heart tracing (ECG)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study will be conducted over 4 weeks and patients will undergo low-level tragus stimulation for 1 hour every day for 4 weeks."
  • "At baseline the following tests will be conducted-6-minute walk distance, vascular function testing using noninvasive device and blood samples will be collected."
  • "A 6MWD and QoL (using Pulmonary hypertension questionnaire) will be performed at baseline and follow up (1 months)."
  • "EKG for heart rate variability, Six minute walk test, Endopat test for endothelial dysfunction would re recorded."
  • "Patients will maintain a diary log for 4 weeks and perform stimulation for 1 hour daily (typically between 4-8pm, during the 2nd diurnal phase of high sympathetic tone)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether gentle stimulation of the tragus, a small flap on the outer ear, can improve blood vessel health, walking distance, and blood test results. It is for adults with Group 1 pulmonary arterial hypertension, or high blood pressure in the lungs. Participants will use the stimulation for 1 hour each day for 4 weeks, with tests before and after.

Patients with Group 1 pulmonary hypertension will be enrolled in this study. Investigators will test the hypothesis of low-level tragal stimulation in patients with pulmonary hypertension. The study will be conducted over 4 weeks and patients will undergo low-level tragus stimulation for 1 hour every day for 4 weeks. At baseline the following tests will be conducted-6-minute walk distance, vascular function testing using noninvasive device and blood samples will be collected. Patient will also undergo a limited echocardiography to assess right ventricular function. After 4 weeks of stimulation patients will come back to undergo these tests again. Investigators hypothesized that low-level tragus stimulation (neuromodulation) will lead to improvement in vascular function, 6-minute walk distance and blood based biomarkers in patients with pulmonary hypertension.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Older than 18 years.
  • Have Group 1 pulmonary arterial hypertension, or high blood pressure in the lungs.
  • Have WHO class II or III symptoms, meaning symptoms limit physical activity.

Who can't join

  • Cannot walk.
  • Use a wheelchair because they cannot walk.
  • Have had a body part removed, such as an arm or leg.
  • Are expected to live less than 3 to 6 months.
  • Have active cancer.
  • Are Spanish-speaking.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion criteria: Patients older than 18 years of age, with pulmonary arterial hypertension (Group 1 PH) and WHO functional class II/III Exclusion:Patients with Inability to walk, wheelchair-bound, amputations, expected survival less than 3 to 6 months, active malignancy patients who are Spanish-speaking. would be excluded from the study.

Study sites (1)

OK