Neuromodulation in Patients With Pulmonary Arterial Hypertension

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT06802380
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Pulmonary Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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 Dates

Start date
Sep 1, 2025
Status verified
Aug 2025
Primary completion
Nov 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LLTS arm
    Patients in this group will undergo low-level tragus stimulation for 1 hour every day for 4 weeks.
  • Sham Comparator: Placebo arm
    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.

Primary Outcome Measure

Heart rate variability [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Oklahoma health sciences CenterOklahoma CityOklahoma73104
Tarun Dasari
[email protected]
405-271-4742
Tarun Dasari, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Oklahoma health sciences Center· Oklahoma City, OK

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