Trial Outcomes & Findings for Noninvasive Neuromodulation to Reserve Diastolic Dysfunction (NCT NCT02983448)
NCT ID: NCT02983448
Last Updated: 2019-06-25
Results Overview
Global longitudinal strain
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
after 1 hour of stimulation
Results posted on
2019-06-25
Participant Flow
Participant milestones
| Measure |
Sham Stimulation First
Sham stimulation delivered at the earlobe (devoid of vagal innervation) is given on first session.
Transcutaneous vagus nerve stimulation delivered at the tragus (vagal innervation) is given on second session.
transcutaneous vagus nerve stimulation: All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized
|
Active Stimulation First
Transcutaneous vagus nerve stimulation delivered at the earlobe (vagal innervation) is given on first session.
Sham stimulation delivered at the tragus (devoid of vagal innervation) is given on second session.
transcutaneous vagus nerve stimulation: All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Noninvasive Neuromodulation to Reserve Diastolic Dysfunction
Baseline characteristics by cohort
| Measure |
All Participants
n=24 Participants
All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
68.2 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after 1 hour of stimulationPopulation: All patients received both active and sham transcutaneous vagus nerve stimulation, with the order being randomized. The comparison is between active and sham stimulation.
Global longitudinal strain
Outcome measures
| Measure |
Sham Stimulation
n=24 Participants
Sham stimulation delivered at the earlobe (devoid of vagal innervation) is given on first session.
Transcutaneous vagus nerve stimulation delivered at the tragus (vagal innervation) is given on second session.
transcutaneous vagus nerve stimulation: All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized
|
Active Stimulation
n=24 Participants
Transcutaneous vagus nerve stimulation delivered at the earlobe (vagal innervation) is given on first session.
Sham stimulation delivered at the tragus (devoid of vagal innervation) is given on second session.
transcutaneous vagus nerve stimulation: All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized
|
|---|---|---|
|
Echocardiographic Markers of Diastolic Dysfunction
|
-21.2 percent
Standard Deviation 3
|
-23.0 percent
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: after 1 hour of stimulationPopulation: All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized. The comparison is between active and sham stimulation.
low frequency to high frequency ratio. This is a measure of sympathovagal balance. A lower value reflects a more favorable balance between sympathetic and parasympathetic (vagal) tone.
Outcome measures
| Measure |
Sham Stimulation
n=24 Participants
Sham stimulation delivered at the earlobe (devoid of vagal innervation) is given on first session.
Transcutaneous vagus nerve stimulation delivered at the tragus (vagal innervation) is given on second session.
transcutaneous vagus nerve stimulation: All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized
|
Active Stimulation
n=24 Participants
Transcutaneous vagus nerve stimulation delivered at the earlobe (vagal innervation) is given on first session.
Sham stimulation delivered at the tragus (devoid of vagal innervation) is given on second session.
transcutaneous vagus nerve stimulation: All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized
|
|---|---|---|
|
Heart Rate Variability Measures
|
3.1 ratio
Standard Deviation 0.4
|
1.8 ratio
Standard Deviation 0.4
|
Adverse Events
Sham Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Stavros Stavrakis
University of Oklahoma Health Sciences Center
Phone: 405-271-4742
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place