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NOT YET RECRUITING
NCT06802380
PHASE1/PHASE2

Neuromodulation in Patients With Pulmonary Arterial Hypertension

Sponsor: University of Oklahoma

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-09-01

Completion Date

2026-12-31

Last Updated

2025-08-27

Healthy Volunteers

No

Interventions

DEVICE

Low-level tragus stimulation

Low-level tragus stimulation will recruit the fibers from the inner part of the tragus of the external ear and sent afferent signals through the greater auricular branch of the vagus nerve. Ultimately the stimulation is transmitted to the dorsal vagal complex and the brainstem thereby modulating the neuronal activity in the vehicle output. Sham stimulation will be performed by clipping the electrode to the ear lobule which will not relay any afferent signals through the greater auricular branch of the vagus nerve.

DEVICE

Sham stimulation

In the sham stimulation the electrodes will be attached to the ear lobule which are devoid of any afferent nerves traveling to the greater auricular branch of the vagus nerve.

Locations (1)

University of Oklahoma health sciences Center

Oklahoma City, Oklahoma, United States