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Prospective Use of Awake Endoscopy for Inspire Activation

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Awake endoscopy
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All subjects

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 23, 2019
Last Updated
July 13, 2021
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03990298
Brief Title
Prospective Use of Awake Endoscopy for Inspire Activation
Official Title
Prospective Use of Awake Endoscopy to Direct Inspire Therapy for Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
June 9, 2020 (Actual)
Study Completion Date
June 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All subjects
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Awake endoscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Distribution of Electrode Configurations Resulting in Greatest Retropalatal Expansion Among Cohort Subjects
Description
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.
Time Frame
One month after surgical implantation of UAS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erica Thaler, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prospective Use of Awake Endoscopy for Inspire Activation

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