Trial Outcomes & Findings for Relief of Acute Bronchoconstriction/Asthma Using the Non-Invasive AlphaCore Device (NCT NCT01532817)
NCT ID: NCT01532817
Last Updated: 2018-04-09
Results Overview
Safety- number of participants with adverse events, including device-related, serious or unanticipated
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
From time subject signs the consent through the 1-week follow-up visit
Results posted on
2018-04-09
Participant Flow
Participant milestones
| Measure |
Alphacore
noninvasive neurostimulation of the vagus nerve
AlphaCore: A single 90 second stimulation to the vagus nerve on the right side of the neck
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Relief of Acute Bronchoconstriction/Asthma Using the Non-Invasive AlphaCore Device
Baseline characteristics by cohort
| Measure |
Alphacore
n=30 Participants
noninvasive neurostimulation of the vagus nerve
AlphaCore: A single 90 second stimulation to the vagus nerve on the right side of the neck
|
|---|---|
|
Age, Customized
Age
|
30 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From time subject signs the consent through the 1-week follow-up visitPopulation: Open label study 30 participants
Safety- number of participants with adverse events, including device-related, serious or unanticipated
Outcome measures
| Measure |
Alphacore
n=30 Participants
noninvasive neurostimulation of the vagus nerve
AlphaCore: A single 90 second stimulation to the vagus nerve on the right side of the neck
|
|---|---|
|
Safety- Number of Participants With Adverse Events
|
10 Participants
|
Adverse Events
Alphacore
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alphacore
n=30 participants at risk
noninvasive neurostimulation of the vagus nerve
AlphaCore: A single 90 second stimulation to the vagus nerve on the right side of the neck
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Local site neck pain
|
3.3%
1/30 • Number of events 1 • From screening visit 1 to visit 3 follow up, 9 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.3%
1/30 • Number of events 1 • From screening visit 1 to visit 3 follow up, 9 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Increased chest congestion
|
3.3%
1/30 • Number of events 1 • From screening visit 1 to visit 3 follow up, 9 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
3.3%
1/30 • Number of events 1 • From screening visit 1 to visit 3 follow up, 9 weeks.
|
|
Musculoskeletal and connective tissue disorders
Sensation of muscle tightness/spasm from right ear to right wrist
|
3.3%
1/30 • Number of events 1 • From screening visit 1 to visit 3 follow up, 9 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Increased mucus in post oropharynx
|
3.3%
1/30 • Number of events 1 • From screening visit 1 to visit 3 follow up, 9 weeks.
|
|
Skin and subcutaneous tissue disorders
Faint localised area of erythema on anterior biceps bilaterally
|
3.3%
1/30 • Number of events 1 • From screening visit 1 to visit 3 follow up, 9 weeks.
|
|
Immune system disorders
Allergic reaction to food
|
3.3%
1/30 • Number of events 1 • From screening visit 1 to visit 3 follow up, 9 weeks.
|
|
Nervous system disorders
Upper body jitteriness
|
3.3%
1/30 • Number of events 1 • From screening visit 1 to visit 3 follow up, 9 weeks.
|
|
Musculoskeletal and connective tissue disorders
Sensation of musculoskeletal tenseness/tightness through upper body
|
3.3%
1/30 • Number of events 1 • From screening visit 1 to visit 3 follow up, 9 weeks.
|
|
Skin and subcutaneous tissue disorders
Right neck skin itching
|
3.3%
1/30 • Number of events 1 • From screening visit 1 to visit 3 follow up, 9 weeks.
|
|
Nervous system disorders
Tingling sensation on right side of neck
|
3.3%
1/30 • Number of events 1 • From screening visit 1 to visit 3 follow up, 9 weeks.
|
|
Musculoskeletal and connective tissue disorders
Torticollis muscular
|
3.3%
1/30 • Number of events 1 • From screening visit 1 to visit 3 follow up, 9 weeks.
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • Number of events 1 • From screening visit 1 to visit 3 follow up, 9 weeks.
|
|
Infections and infestations
Viral respiratory syndrome
|
6.7%
2/30 • Number of events 2 • From screening visit 1 to visit 3 follow up, 9 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60