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Early feasibility study to estimate the functionality of a novel intervention based on non-invasive transcutaneous electrical stimulation of the hypoglossal nerve to reduce the Apnea Hypopnea Index (AHI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TUAS | Experimental | Transcutaneous upper airway stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Upper Airway Stimulation Device | Device | Multiple frequency stimulation of the hypoglossal nerve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea Hypopnea Index | Episodes of apnea and/or hypopnea scored during the course of sleep study | Overnight (day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial Oxygen Saturation (SaO2) | SaO2 levels during the course of sleep study compared to baseline | Overnight (day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quality | Subjective Questionnaire | Overnight (day 1) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee Shangold, MD | ENT & Allergy Associates, LLP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United Diagnostics | Commack | New York | 11725 | United States |
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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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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |