Characterizing Bilateral Hypoglossal Nerve Stimulation During Drug-Induced Sleep Endoscopy

Not Applicable

Not yet recruiting

• Conditions: OSA - Obstructive Sleep Apnea

• Registration Number: NCT06661629
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-16
• Study First Submitted QC: 2024-10-24
• Study First Posted: 2024-10-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23
• Study Start: 2025-09-01
• Primary Completion: 2027-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Adults (≥ 22yrs) willing and capable of providing informed consent
• Implanted with the Inspire hypoglossal nerve stimulator

Exclusion Criteria

• • Pregnant women*

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Upper Airway Collapsability Measures	During DISE - during the 20 minutes that the Drug Induced Sleep Endoscopy Occurs	Pcrit - Critical Pressure, the maximum CPAP level where the airway is obstructed

Secondary Outcome Measures

Name	Time	Method
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