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This study will look at the safety, improving symptoms and decreasing the length of stay of patients admitted to the hospital with COPD.
The primary safety measurement for this study is the type, occurrence and severity of adverse events (anticipated and unanticipated), including serious and non-serious device-related events.
The primary outcome measure is hospital length of stay (LOS) defined as the number of days from hospital admission to the date the subject meets the medical elements of the GOLD Discharge Criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AlphaCore 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AlphaCore Device | Device | multiple stimulation treatments per day for duration of hospitalization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Length of Stay in the Hospital | 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) | Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal |
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Inclusion Criteria:
Exclusion Criteria:
Has a confirmed history of asthma (by pulmonary functions, response to ß-agonists and variable symptoms)
Has a history of lung cancer or Talc lung
Is admitted to the emergency care facility with a diagnosis of the following, confirmed on CXR, ventilation/perfusion scanning or computerized tomography (CT):
Is admitted to the emergency care facility with a working diagnosis of:
Is admitted to the emergency care facility and/or hospital with a working diagnosis of:
Other severe cardiovascular acute diseases (such as uncontrolled hypertension, recent onset rapid atrial fibrillation and severe ventricular arrhythmias)
Is at risk of imminent respiratory collapse:
Has a condition in which collecting blood would be contraindicated or blood samples are unable to be obtained;
Has an abscess or other infection, lesion (including lymphadenopathy), surgical scar, congenital changes or broken skin at the treatment site on the neck;
Has confirmed severe sepsis or septic shock
Has a fever > 38.0° C
Has clinically significant changes in blood pressure or is receiving vasopressors to maintain blood pressure
Has an implanted electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, automated implantable cardioverter defibrillators (AICD), vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant
Has a history of carotid endarterectomy or vascular neck surgery on the right side
Has implanted metal cervical spine hardware
Has a condition that would interfere with completing the self-assessment questionnaires
Is pregnant or breast feeding
Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days
Belongs to a population or has any condition such that the investigator believes his or her ability to provide informed consent, comply with follow-up requirements or provide self-assessments is compromised (e.g., homeless, developmentally disabled, prisoner)
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Potential study subjects will be provided a study information sheet (informed consent form) to review. Those who are interested in participating will provide signed informed consent and then be screened for eligibility (inclusion/exclusion criteria). Subjects meeting the inclusion/exclusion criteria will be assigned a study ID number, randomized and enrolled in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Brian Rowe, M.D. | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edmonton Hospital | Edmonton | Alberta | T6G,2B7 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety population
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Length of Stay in the Hospital | 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) | Safety population | Posted | Mean | Full Range | Days | Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal |
|
Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-ST elevation myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs | electroCore LLC | +1 973 355 6683 | clinical@electrocorellc.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Complete CBC and blood gases will be drawn at different time points to establish the medical condition of the subjects.
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 1 |
| 2 |
| EG001 | 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 | 0 | 2 | 0 | 2 | 1 | 2 |
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Confusion/ Delirium | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Acute exacerbations of chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |