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NCT06802380 · ClinicalTrials.gov registry record · Phase 1
Neuromodulation in Patients With Pulmonary Arterial Hypertension
A Phase 1 study, sponsored by University of Oklahoma.
- Not yet
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT06802380: Clinical Trial Phase 1 study, sponsored by University of Oklahoma.
NCT06802380 is a Phase 1 study that has not yet begun recruiting, run by University of Oklahoma. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06802380, a Phase 1 study, has not yet begun recruiting, sponsored by University of Oklahoma.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Change in the heart rate variability metrics. These are reflective of the autonomic tone and the imbalance. Investigators hypothesized that using low-level tragus stimulation in patients with pulmonary hypertension the heart rate variability will be favorably affected using low-level tragus stimulation compared to sham stimulation. Time domain metrics are usually measured using variation of the standard R-R interval on the EKG in milliseconds.
Interventions
- DEVICE Sham stimulation
- DEVICE Low-level tragus stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-09-01 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What is known before NCT06802380 opens enrollment
NCT06802380 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham stimulation is the first listed.
NCT06802380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06802380 about?
NCT06802380 is a clinical study titled "Neuromodulation in Patients With Pulmonary Arterial Hypertension". 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 ever...
What is the current status of trial NCT06802380?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2025-09-01. Estimated completion is 2026-12-31.
What interventions are being tested in trial NCT06802380?
The interventions under investigation include: Sham stimulation (DEVICE), Low-level tragus stimulation (DEVICE).
Who is sponsoring clinical trial NCT06802380?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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