Prospective Use of Awake Endoscopy for Inspire Activation

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Diagnostic Test: Awake endoscopy

• Registration Number: NCT03990298
• Lead Sponsor: University of Pennsylvania

Brief Summary

The aim of this study is to examine a new method of device configuration for the Inspire upper airway stimulator. First, the investigators will attempt to determine optimal configuration by quantifying changes in upper airway size with different implant configurations using awake nasal endoscopy. The configuration/voltage that results in the greatest increase in upper airway size and is tolerated by the patient will be selected. Participants will then undergo a sleep study so that increased airway size may be correlated with changes in sleep study parameters including AHI and oxygen desaturation index (ODI). Airway size and sleep study parameters using the standard device configuration (+-+)/voltage will be compared to airway size and sleep study parameters using the test, or "optimal," configuration/voltage to determine the usefulness of awake endoscopy in activation of the Inspire device.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-06-17
• Study First Posted: 2019-06-18
• Primary Completion: 2020-06-09
• Study Completion: 2020-06-09
• Results First Submitted: 2021-03-17
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-13
• Last Update Submitted: 2021-07-13
• Results First Posted: 2021-08-04
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Patients with moderate to severe OSA who have undergone Inspire UAS implantation by the principal investigator
• Must have symptoms of OSA prior to Inspire implantation
• AHI between 15 and 65, where central and mixed apnea is 25% or more, and the level of collapse is in the soft palate area BMI less than 32
• Age 18 or above

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Exclusion Criteria

• Significant central sleep apnea
• Presence of other sleep disorders
• History of neurologic or neuromuscular disease
• Historical or present substance abuse
• Bleeding disorders
• Autoimmune diseases that increase risk of nasal trauma such as Wegener's, Sarcoidosis, etc.
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects	Awake endoscopy	Awake endoscopic exam will be performed to measure airway size in the retropalatal and retroglossal upper airway regions using different Inspire implant configurations and voltages.

Primary Outcome Measures

Name	Time	Method
Distribution of Electrode Configurations Resulting in Greatest Retropalatal Expansion Among Cohort Subjects	One month after surgical implantation of UAS	The hypoglossal nerve stimulator has a triode (three electrodes) that is wrapped around the nerve. Each electrode can be configured to either "Off," "Positive," or "Negative." For each electrode configuration we determined the percentage of patients with the greatest retropalatal cross-sectional area resulting from stimulation.

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States