Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to characterize the upper airway of Latin American subjects who have been diagnosed with moderate/severe obstructive sleep apnea (OSA) and assess response to a neuromodulation therapy to treat OSA.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trans-Q DISE treated subjects | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug Induced Sleep Endoscopy with PNS | Diagnostic Test | Enrolled subjects will complete an overnight PSG and then undergo a DISE procedure with a 30-minute research period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Understand the difference in response compared to prior U.S. based studies to the response in Latin America. | Reviewing phrenic nerve stimulation response to literature of US based population | enrollment to study exit, usually within 3 weeks of screening |
| Use VOTE scoring to characterize the type of upper airway collapse as assessed via DISE. | Upper Airway will be characterized using VOTE scoring as assessed by a qualified, trained Independent Reviewer. | enrollment to study exit, usually within 3 weeks of screening |
| Use VOTE scoring and airway opening measurements to characterize the effect of Phrenic Nerve Stimulation and if it is a viable and effective treatment of OSA and correlation to phenotype. | In combination with VOTE scoring and airway opening measurements, the effects of phrenic nerve stimulation will be compared across treated patient population. | enrollment to study exit, usually within 3 weeks of screening |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Director of Clinical Operations | Contact | 866-675-4430 | andreas@lunairmedical.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanatorio Americano | Recruiting | Asunción | Paraguay |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |