OSA - Obstructive Sleep Apnea
Conditions
Brief summary
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.
Interventions
DEVICENerve stimulation
The intervention is testing the effect of unilateral versus bilateral hypoglossal nerve stimulation on upper airway collapsibility during drug-induced sleep endoscopy
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (≥ 22yrs) willing and capable of providing informed consent * Implanted with the Inspire hypoglossal nerve stimulator
Exclusion criteria
* • Pregnant women\*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper Airway Collapsability Measures | During DISE - during the 20 minutes that the Drug Induced Sleep Endoscopy Occurs. | PhOP - Pharangeal Opening Pressure, the minimum CPAP level needed to have an unobstructed airway |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Voltage Requirements | During DISE - During the 20 minutes during which the Drug Induced Sleep Endoscopy occurs | Difference in voltage between Inspire Device and External Stimulator during unilateral and bilateral stimulation |
Outcome results
None listed