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The objective of this study is to assess the efficacy of the eXciteOSA device amongst a sample of patients with moderate OSA. The study is a multi-center, prospective, open-label, randomized, parallel-arm trial of eXciteOSA (administered at two doses) versus no-therapy for six weeks. Up to 120 participants will be enrolled, in order to randomized n=62.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapy Dose-A | Experimental | Neuromuscular electrical stimulation; two 20-minute sessions per day. |
|
| Therapy Dose-B | Experimental | Neuromuscular electrical stimulation; one 30-minute session per day. |
|
| No Therapy | No Intervention | Under the care of the referring physician, with no therapy applied |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eXciteOSA | Device | eXciteOSA |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference in the delta-REI (baseline to follow-up) between therapy (Dose-A and Dose-B combined) and no therapy | Six weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yasser Zayni | yasser.z@signifiermedical.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Disorders Center of Alabama | Birmingham | Alabama | 35213 | United States | ||
| Delta Waves |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Colorado Springs |
| Colorado |
| 80918 |
| United States |
| Florida Lung & Sleep Associates | Lehigh Acres | Florida | 33971 | United States |
| Pulmonary and Critical Care Associates of Baltimore | Baltimore | Maryland | 21286 | United States |
| Clayton Sleep Institute | St Louis | Missouri | 63143 | United States |
| Ohio Sleep Medicine Institute | Dublin | Ohio | 43017 | United States |
| Bogan Sleep Consultants | Columbia | South Carolina | 29201 | United States |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |