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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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Day 7 reported

Results posted on

2025-04-20

Participant Flow

Participant milestones

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

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

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=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
9 Participants
n=93 Participants
1 Participants
n=4 Participants
10 Participants
n=27 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Sex: Female, Male
Female
0 Participants
n=93 Participants
1 Participants
n=4 Participants
1 Participants
n=27 Participants
Sex: Female, Male
Male
9 Participants
n=93 Participants
0 Participants
n=4 Participants
9 Participants
n=27 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Asian
1 Participants
n=93 Participants
0 Participants
n=4 Participants
1 Participants
n=27 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=93 Participants
0 Participants
n=4 Participants
1 Participants
n=27 Participants
Race (NIH/OMB)
White
7 Participants
n=93 Participants
1 Participants
n=4 Participants
8 Participants
n=27 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants

PRIMARY outcome

Timeframe: Day 7 reported

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.

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Older Cohort

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

Eric Porges, Associate Profressor

University of Florida

Phone: (352) 294-5838

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place