Trial Outcomes & Findings for Home Operations Utilizing Stimulation (NCT NCT04484285)
NCT ID: NCT04484285
Last Updated: 2025-04-20
Results Overview
This is a standard version of a usability scale. Subjects will be given 10 statements regarding the usability of the equipment they used, and they will report how much they agree with each statement on a 1 - 5 scale (1 is strongly disagree and 5 is strongly agree). The score range is 10-50 where 50 demonstrates the highest acceptance of the usability of the device and 10 demonstrates the lowest acceptance of the usability of the device.
COMPLETED
NA
10 participants
Day 7 reported
2025-04-20
Participant Flow
Participant milestones
| Measure |
Younger Cohort
Healthy individuals aged 18 - 50
Transcutaneous Vagal Nerve Stimulation (tVNS): vagal nerve stimulation completed at home for 7 days.
|
Older Cohort
Healthy individuals aged 50 - 85
Transcutaneous Vagal Nerve Stimulation (tVNS): vagal nerve stimulation completed at home for 7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
1
|
|
Overall Study
COMPLETED
|
6
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Younger Cohort
Healthy individuals aged 18 - 50
Transcutaneous Vagal Nerve Stimulation (tVNS): vagal nerve stimulation completed at home for 7 days.
|
Older Cohort
Healthy individuals aged 50 - 85
Transcutaneous Vagal Nerve Stimulation (tVNS): vagal nerve stimulation completed at home for 7 days.
|
|---|---|---|
|
Overall Study
Unable to operate stimulator
|
3
|
0
|
Baseline Characteristics
Home Operations Utilizing Stimulation
Baseline characteristics by cohort
| Measure |
Younger Cohort
n=9 Participants
Healthy individuals aged 18 - 50
Transcutaneous Vagal Nerve Stimulation (tVNS): vagal nerve stimulation
|
Older Cohort
n=1 Participants
Healthy individuals aged 50 - 85
Transcutaneous Vagal Nerve Stimulation (tVNS): vagal nerve stimulation
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 7 reportedThis is a standard version of a usability scale. Subjects will be given 10 statements regarding the usability of the equipment they used, and they will report how much they agree with each statement on a 1 - 5 scale (1 is strongly disagree and 5 is strongly agree). The score range is 10-50 where 50 demonstrates the highest acceptance of the usability of the device and 10 demonstrates the lowest acceptance of the usability of the device.
Outcome measures
| Measure |
Younger Cohort
n=6 Participants
Healthy individuals aged 18 - 50
Transcutaneous Vagal Nerve Stimulation (tVNS): vagal nerve stimulation
|
Older Cohort
n=1 Participants
Healthy individuals aged 50 - 85
Transcutaneous Vagal Nerve Stimulation (tVNS): vagal nerve stimulation
|
|---|---|---|
|
System Usability Scale
|
46.25 score on a scale
Standard Deviation 18.53
|
10 score on a scale
Standard Deviation NA
Standard Deviation not calculated for one participant
|
Adverse Events
Younger Cohort
Older Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Eric Porges, Associate Profressor
University of Florida
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place