Trial Outcomes & Findings for Vagus Nerve Stimulation for Management of Bronchoconstriction in Patients Hospitalized With COPD Exacerbations (NCT NCT01612793)
NCT ID: NCT01612793
Last Updated: 2019-02-28
Results Overview
The primary outcome measure was hospital length of stay (LOS) defined as the number of days from hospital admission to the date the subject met the medical elements of the GOLD Discharge Criteria. (Global Initiative for Chronic Obstructive Lung Disease report, "Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease", Revised 2011)
Recruitment status
TERMINATED
Target enrollment
4 participants
Primary outcome timeframe
Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal
Results posted on
2019-02-28
Participant Flow
Participant milestones
| Measure |
AlphaCore Active Device
AlphaCore device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease and receive an electrical stimulation to the vagus nerve to help open the subjects airways during the subjects stay in the hospital.
AlphaCore Device: multiple stimulation treatments per day for duration of hospitalization
|
AlphaCore Sham Device
AlphaCore Sham device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease, Sham device has no signal to the vagus nerve.
AlphaCore ShamDevice: multiple stimulation treatments per day for duration of hospitalization
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vagus Nerve Stimulation for Management of Bronchoconstriction in Patients Hospitalized With COPD Exacerbations
Baseline characteristics by cohort
| Measure |
AlphaCore Active Device
n=2 Participants
AlphaCore device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease and receive an electrical stimulation to the vagus nerve to help open the subjects airways during the subjects stay in the hospital.
AlphaCore Device: multiple stimulation treatments per day for duration of hospitalization
|
AlphaCore Sham Device
n=2 Participants
AlphaCore Sham device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease, Sham device has no signal to the vagus nerve.
AlphaCore ShamDevice: multiple stimulation treatments per day for duration of hospitalization
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=93 Participants
|
72 years
n=4 Participants
|
69 years
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
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
4 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptalPopulation: Safety population
The primary outcome measure was hospital length of stay (LOS) defined as the number of days from hospital admission to the date the subject met the medical elements of the GOLD Discharge Criteria. (Global Initiative for Chronic Obstructive Lung Disease report, "Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease", Revised 2011)
Outcome measures
| Measure |
AlphaCore Active Device
n=2 Participants
AlphaCore device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease and receive an electrical stimulation to the vagus nerve to help open the subjects airways during the subjects stay in the hospital.
AlphaCore Device: multiple stimulation treatments per day for duration of hospitalization
|
AlphaCore Sham Device
n=2 Participants
AlphaCore Sham device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease, Sham device has no signal to the vagus nerve.
AlphaCore ShamDevice: multiple stimulation treatments per day for duration of hospitalization
|
|---|---|---|
|
Change in the Length of Stay in the Hospital
|
9 Days
Interval 7.0 to 11.0
|
5.5 Days
Interval 5.0 to 6.0
|
Adverse Events
AlphaCore Active Device
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AlphaCore Sham Device
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AlphaCore Active Device
n=2 participants at risk
AlphaCore device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease and receive an electrical stimulation to the vagus nerve to help open the subjects airways during the subjects stay in the hospital.
AlphaCore Device: multiple stimulation treatments per day for duration of hospitalization
|
AlphaCore Sham Device
n=2 participants at risk
AlphaCore Sham device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease, Sham device has no signal to the vagus nerve.
AlphaCore ShamDevice: multiple stimulation treatments per day for duration of hospitalization
|
|---|---|---|
|
Cardiac disorders
Non-ST elevation myocardial infarction
|
0.00%
0/2 • Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal
|
50.0%
1/2 • Number of events 1 • Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal
|
50.0%
1/2 • Number of events 1 • Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal
|
|
Psychiatric disorders
Confusion/ Delirium
|
0.00%
0/2 • Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal
|
50.0%
1/2 • Number of events 1 • Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal
|
50.0%
1/2 • Number of events 1 • Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal
|
|
Respiratory, thoracic and mediastinal disorders
Acute exacerbations of chronic obstructive pulmonary disease
|
50.0%
1/2 • Number of events 1 • Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal
|
0.00%
0/2 • Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60