Prospective Use of Awake Endoscopy for Inspire Activation

Obstructive Sleep Apnea Clinical Trial

Official title:

Prospective Use of Awake Endoscopy to Direct Inspire Therapy for Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03990298
• Other study ID #: 828956
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: June 9, 2020

Study information

• Verified date: July 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 9, 2020
• Est. primary completion date: June 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• 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. The optimal test configuration determined on endoscopy will be tested during a sleep study and compared to the standard-of-care device configuration, with improvements in sleep study outcomes indicating that awake endoscopy is useful during Inspire implant activation.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of Electrode Configurations Resulting in Greatest Retropalatal Expansion Among Cohort Subjects	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.	One month after surgical implantation of UAS