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出境医 / 临床实验 / Prospective Use of Awake Endoscopy for Inspire Activation

Prospective Use of Awake Endoscopy for Inspire Activation

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Diagnostic Test: Awake endoscopy Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prospective Use of Awake Endoscopy to Direct Inspire Therapy for Obstructive Sleep Apnea
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : June 9, 2020
Actual Study Completion Date : June 9, 2020
Arms and Interventions
Arm Intervention/treatment
All subjects
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.
 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.
Outcome Measures
Primary Outcome Measures :
  1. Change in AHI [ Time Frame: Visit 2 - Titration Polysomnogram 8-10 weeks post-implant ]
    Change in Apnea-Hypopnea Index with test configuration compared to standard configuration

  2. Change in ODI [ Time Frame: Visit 2 - Titration Polysomnogram 8-10 weeks post-implant ]
    Change in oxygen desaturation index with test configuration compared to standard configuration


Secondary Outcome Measures :
  1. Change in airway size [ Time Frame: Visit 1 - Awake Endoscopy 4 weeks post-implant ]
    Percent changes in cross-sectional airway size at the level of the retropalatal and retroglossal regions using different device configuration settings

  2. Correlation of change in airway size to change in AHI/ODI [ Time Frame: Visit 1 (4 weeks post-implant) and Visit 2 (8-10 weeks post-implant) ]
    The degree to which changes in airway size correlate with changes in sleep study parameters including AHI and ODI


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Erica Thaler, MD University of Pennsylvania
Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE June 18, 2019
Last Update Posted Date July 9, 2020
Actual Study Start Date  ICMJE November 1, 2018
Actual Primary Completion Date June 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Change in AHI [ Time Frame: Visit 2 - Titration Polysomnogram 8-10 weeks post-implant ]
    Change in Apnea-Hypopnea Index with test configuration compared to standard configuration
  • Change in ODI [ Time Frame: Visit 2 - Titration Polysomnogram 8-10 weeks post-implant ]
    Change in oxygen desaturation index with test configuration compared to standard configuration
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Change in airway size [ Time Frame: Visit 1 - Awake Endoscopy 4 weeks post-implant ]
    Percent changes in cross-sectional airway size at the level of the retropalatal and retroglossal regions using different device configuration settings
  • Correlation of change in airway size to change in AHI/ODI [ Time Frame: Visit 1 (4 weeks post-implant) and Visit 2 (8-10 weeks post-implant) ]
    The degree to which changes in airway size correlate with changes in sleep study parameters including AHI and ODI
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Use of Awake Endoscopy for Inspire Activation
Official Title  ICMJE Prospective Use of Awake Endoscopy to Direct Inspire Therapy for Obstructive Sleep Apnea
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Obstructive Sleep Apnea
Intervention  ICMJE 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.
Study Arms  ICMJE All subjects
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: Diagnostic Test: Awake endoscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2020) 		17
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2019) 		30
Actual Study Completion Date  ICMJE June 9, 2020
Actual Primary Completion Date June 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03990298
Other Study ID Numbers  ICMJE 828956
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erica Thaler, MD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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