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NCT02983448 · ClinicalTrials.gov registry record · NA
Noninvasive Neuromodulation to Reserve Diastolic Dysfunction
A NA study, sponsored by University of Oklahoma.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT02983448 is a NA study that has completed, run by University of Oklahoma. The registered enrollment target is 24 participants.
The verdict
NCT02983448, a NA study, has completed, sponsored by University of Oklahoma.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study 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).
Interventions
- DEVICE transcutaneous vagus nerve stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-12 |
| Est. Completion | 2018-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02983448
The ClinicalTrials.gov registry entry for NCT02983448 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Oklahoma, which has 358 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which transcutaneous vagus nerve stimulation is the first listed.
NCT02983448 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02983448 about?
NCT02983448 is a clinical study titled "Noninvasive Neuromodulation to Reserve Diastolic Dysfunction". 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 ...
What is the current status of trial NCT02983448?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2016-12. Estimated completion is 2018-04.
What interventions are being tested in trial NCT02983448?
The interventions under investigation include: transcutaneous vagus nerve stimulation (DEVICE).
Who is sponsoring clinical trial NCT02983448?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
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