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| Name | Class |
|---|---|
| Center for Bioengineering Innovation and Design | UNKNOWN |
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The purpose of this study is to examine 1) effects of cutaneous electrical trigeminal nerve stimulation (eTNS) on respiratory control in healthy volunteers and 2) explore the potential of this approach to mitigate dyspnea in patients with chronic obstructive lung disease (COPD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Experimental |
| |
| Participants With COPD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Stimulation | Procedure | Active Non-Invasive Trigeminal Nerve Stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with a >4 bpm decrease in heart rate | Trigeminal autonomic engagement. Proportion of participants with a >4 bpm decrease in heart rate during active eTNS compared to sham stimulation. | 1 day |
| Proportion of enrolled participants who complete all randomized stimulation conditions | Protocol completion rate measured by proportion of enrolled participants who complete all randomized stimulation conditions. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Minute Ventilation | Minute Ventilation | 1 day |
| Dyspnea severity as assessed by the Borg CR10 scale | Borg CR10 score before and during stimulation. Scale range 0-10 higher score worse severity |
| Measure | Description | Time Frame |
|---|---|---|
| Change in heart rate | changes in heart rate in response to stimulation | 1 day |
| Change in heart rate variability | changes in heart rate variability in response to stimulation |
Arm1 - Healthy Volunteers
Inclusion Criteria:
Exclusion Criteria:
Arm 2 -COPD
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luu Pham, MD | Contact | 410-550-2118 | luu.pham@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Luu Pham, MD | Johns Hopkins University | Principal Investigator |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Sham Stimulation | Procedure | Sham Stimulation |
|
| Fan therapy | Procedure | Handheld fan |
|
| 1 day |
| 1 day |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |