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The objectives of this study are to evaluate the feasibility of the remedē® Dual Channel System at implant and overnight sleep studies and to assess chronic safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual Channel Stimulation | Device | implant of dual channel stimulation device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety through 12 months | Serious adverse event related to implant procedure, device, or stimulation | 12 Months post implant |
| Successful Implantation | Successful Implantation of dual channel system | implant procedure |
| Improvement in sleep disordered breathing | Demonstration of the acute prevention of sleep disordered breathing events during attended sleep study. | 12 months post implant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samuel Kolapo | Contact | 205-441-9519 | samuel.kolapo@zoll.com | |
| Kathy McPherson | Contact | 615-613-6321 | kmcpherson@zoll.com |
| Name | Affiliation | Role |
|---|---|---|
| Robin Germany, MD | ZOLL Respicardia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Insomnia and Sleep Institute of Arizona LLC | Recruiting | Scottsdale | Arizona | 85255 | United States |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| The University of Michigan Health-West | Recruiting | Wyoming | Michigan | 49519 | United States |
|
| The Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
|
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |