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Study terminated prior to enrollment following mutual agreement between the sponsor and the site. No patients were recruited. No data was collected.
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The study will investigate the treatment effect of bilateral genioglossus muscle stimulation on upper airway collapsibility during drug-induced sleep endoscopy in patients implanted with the Inspire hypoglossal nerve stimulator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unilateral vs Bilateral HGNS | Experimental | All participants will undergo both unilateral and bilateral hypoglossal nerve stimulation during a single drug-induced sleep endoscopy exam. The voltage will be adjusted [0.1 5.0 V]. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerve stimulation | Device | The intervention is testing the effect of unilateral versus bilateral hypoglossal nerve stimulation on upper airway collapsibility during drug-induced sleep endoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Upper Airway Collapsability Measures | PhOP - Pharangeal Opening Pressure, the minimum CPAP level needed to have an unobstructed airway | During DISE - during the 20 minutes that the Drug Induced Sleep Endoscopy Occurs. |
| Upper Airway Collapsability Measures | Pcrit - Critical Pressure, the maximum CPAP level where the airway is obstructed | During DISE - during the 20 minutes that the Drug Induced Sleep Endoscopy Occurs |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Voltage Requirements | Difference in voltage between Inspire Device and External Stimulator during unilateral and bilateral stimulation | During DISE - During the 20 minutes during which the Drug Induced Sleep Endoscopy occurs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raj C Dedhia, MD | Penn Medicine | Principal Investigator |
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CTA is being drafted for data sharing between Penn Medicine and Inspire Medical Systems - IPD would be shared between Penn and Inspire.
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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 |