NCT02983448

Noninvasive Neuromodulation to Reserve Diastolic Dysfunction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a 2x2 cross over pilot study using low level transcutaneous vagus nerve stimulation (LLTS) to reverse diastolic dysfunction in patients with diastolic dysfunction. All patients will receive 2 separate, 1-hour sequences, at least 1 day apart, of active and sham LLTS, but the sequence will be randomized. Patients will be randomly assigned (1:1) to active/sham or sham/active LLTS. LLTS will be performed using a transcutaneous electrical nerve stimulation (TENS) device with electrodes attached to the tragus of the ear, which is innervated by auricular branch of the vagus nerve. Echocardiography will be performed after 30 minutes of LLTS or sham stimulation to assess diastolic function. Five-minute ECGs will be obtained for HRV analysis every 15 minutes of stimulation (total of 4 recordings).

Conditions

• Heart Failure, Diastolic

Interventions

Type	Name	Description
DEVICE	transcutaneous vagus nerve stimulation	All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-03-01
• Completion: 2018-04-01
• First posted: 2016-12-06
• Last updated: 2019-06-25
• Results posted: 2019-06-11

Locations

1 site across 1 country: United States