COPD patient that are hospitalised with an exacerbation
Conditions
Interventions
Intervention subjects will receive non-invasive vagal nerve stimulation three times a day, according to the device instructions, starting on the first day following admission, until the day of dischar
Sponsors
Medisch Spectrum Twente, Enschede
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age > 40 years, male or female; 2. Ability to understand and read Dutch; 3. Diagnosis of COPD stage II, III or IV according to GOLD; 4. Hospitalised at ward A4 or C4; 5. Is able to give written informed consent; 6. Borg score <3 at the first day of hospitalization.
Exclusion criteria
Exclusion criteria: 1. Has an abscess or other infection or lesion (including lymphadenopathy) at the AlphaCore™ treatment site; 2. Is currently implanted with an electrical and/or neurostimulator device, such as cardiac pacemaker, defibrillator, vagus neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant; 3. Subjects with metal implants including but not limited to stents, bone plates and bone screws, at or near the treatment area; 4. Has a history of carotid endarterectomy or vascular neck surgery on the right side; 5. A history of syncope or seizures during last year. Use of beta blockers; 6. Known carotid artery stenosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the time to discharge. This will be measured in days from the day of admission. If a patient is admitted between 2400 h and 1200 h, the day of admission is counted as 1 day; if the patient is admitted after 1200 h, the day of admission is counted as 0.5 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Breathlessness, measured through the BORG scale from 0 (no breathlessness) until 10 (extreme breathlessness), before and after (sham)stimulation; 2. Change in breathlessness (Borg score), measured in hours; 3. Airway resistance, measured with Forced Oscillation Technique (FOT); 4. Description of position of the vagal nerve, on the left and right side of the neck, through a one-time ultrasound examination; 5. Adverse Events. | — |
Contacts
Public ContactPetra Graaf, de
Onderzoeksbureau Longeneeskunde Medisch Spectrum Twente Postbus 50000
Outcome results
None listed