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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: Completed NA study, sponsored by University of Oklahoma.
NCT02983448 is a NA study that has completed, run by University of Oklahoma. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Global longitudinal strain
Interventions
- DEVICE transcutaneous vagus nerve stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-12 |
| Est. Completion | 2018-04 |
| Phase | NA |
What the finished NCT02983448 record still lists
NCT02983448 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which transcutaneous vagus nerve stimulation is the first listed.
NCT02983448 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02983448's enrollment target sits among peer trials
24 1736th of 2000 higher than 246 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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