Neuromodulation in Patients With Pulmonary Arterial Hypertension

NCT06802380 | Not Yet Recruiting Phase 1 DMC FDA Device

• 1 other identifier: 17677
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Hypertension

Keywords

Neuromodulation; Endothelial function; 6-minute walk distance; Right ventricular function

Outcome Measures

Primary Outcomes (1)

• Heart rate variability

  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.

  4 weeks

Secondary Outcomes (1)

• 6-minute walk distance

  4 weeks

Other Outcomes (2)

• Right ventricular function

  4 weeks

• Endothelial oxidative stress

  4 weeks

Study Arms (2)

LLTS arm

EXPERIMENTAL

Patients in this group will undergo low-level tragus stimulation for 1 hour every day for 4 weeks.

Device: Low-level tragus stimulation

Placebo arm

SHAM COMPARATOR

Patient will undergo stimulation but on the ear lobule which is devoid of any vagus nerve innervation. This will be used as a sham comparison group.

Device: Sham stimulation

Interventions

Low-level tragus stimulation DEVICE

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.

LLTS arm

Sham stimulation DEVICE

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.

Placebo arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma health sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tarun Dasari, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarun Dasari, MD

CONTACT

4052714742; tarun-dasari@ouhsc.edu

Skylar Cheatham

CONTACT

4052714742; skylar-cheatham@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both patient's and principal investigator and outcomes assessor will be blinded to the allocation am of the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical study using low-level tragus stimulation compared to sham stimulation.

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: January 31, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

US (1)