Pediatric Post-Approval Registry

February 24, 2025 updated by: Inspire Medical Systems, Inc.

Inspire Pediatric Post-Approval Registry

This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.

Subjects will be recruited in accordance with the approved Inspire UAS indication for use and will only include those subjects who are within the new age indication (18-21 years of age). Implanted subjects must meet the registry eligibility criteria. Those subjects that are enrolled but fail to meet the eligibility criteria will be considered screen failures.

This registry will collect safety and effectiveness data on 60 implanted subjects at a minimum of 5 qualified clinical centers in the United States.

Study data will be collected at the following timepoints:

Baseline (pre-implant) Implant Activation (1 month post-implant) 6 Months post-implant

1, 2, 3, 4, 5 years post-implant

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Childrens Hospital of Colorado
        • Principal Investigator:
          • Norman Friedman, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Terminated
        • Children's Healthcare of Atlanta
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University
        • Principal Investigator:
          • Eileen Raynor, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Childrens Hospital
        • Principal Investigator:
          • David Smith, MD
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19406
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
        • Principal Investigator:
          • Lisa Elden, MD
      • Sewickley, Pennsylvania, United States, 15143
        • Recruiting
        • Children's Hospital of Pittsburgh
        • Contact:
        • Principal Investigator:
          • Rachel Whelan, MD
    • Texas
      • Dallas, Texas, United States, 75207
        • Recruiting
        • University of Texas Southwestern/Children's Hospital of Dallas
        • Contact:
        • Principal Investigator:
          • Ron Mitchell, MD
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Children's Hospital of the King's Daughters/East Virginia Medical School
        • Principal Investigator:
          • Cristina Baldassari, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 21 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA).

Description

Inclusion Criteria:

  1. Subject is between 18 and 21 years of age;
  2. Subject has a diagnosis of moderate to severe OSA (15 ≤ AHI ≤ 65) based on a recent sleep study;
  3. Subject has documented failure of, or intolerance to, positive airway pressure treatments, despite attempts to improve compliance;
  4. Subject is contraindicated for, or not effectively treated by, adenotonsillectomy;
  5. Subject has followed standard of care in considering all other alternative/adjunct therapies;
  6. Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;
  7. Subject is willing and able to return for follow-up visits, undergo sleep studies (including in-lab and at-home), and complete questionnaires related to the registry;
  8. Subject is willing and able to provide informed consent.

Exclusion Criteria:

  1. Subject has a combination of central + mixed apneas > 25% of the total apnea-hypopnea index (AHI);
  2. Subject has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate;
  3. Subject has any condition or procedure that has compromised neurological control of the upper airway;
  4. Subject is unable, or does not have the necessary assistance, to operate the patient remote;
  5. Subject is pregnant or plans to become pregnant;
  6. Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System;
  7. Subject has a terminal illness with life expectancy < 12 months;
  8. Any other reason the investigator deems the subject is unfit for participation in the registry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Registry Population
Pediatric subjects (age 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation System for the treatment of moderate to severe obstructive sleep apnea (OSA)
Device: Inspire Upper Airway Stimulation System
Implant of the Inspire Upper Airway Stimulation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of device and/or procedure related adverse events over time
Time Frame: Implant through 5 years post-implant
relevant adverse events will be collected and reported
Implant through 5 years post-implant
Evaluation of the improvement of Apnea Hypopnea Index (AHI) over time
Time Frame: through 5 years post-implant
Baseline (pre-implant) AHI compared to AHI after implant (collected and reported at annual study visits). The Apnea Hypopnea Index (AHI) is the number of apnea and hypopnea events per hour of sleep. A lower AHI indicates less severe sleep apnea.
through 5 years post-implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of improvement in Oxygen Desaturation Index (ODI) over time
Time Frame: through 5 years post-implant
Baseline (pre-implant) Oxygen Desaturation Index (ODI) compared to ODI after implant (collected and reported at annual study visits). The Oxygen Desaturation Index (ODI) is the number of oxygen desaturations, with at least a 4% drop from baseline, per hour. A lower ODI indicates less severe sleep apnea.
through 5 years post-implant
Evaluation of improvement in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) < 90%) over time
Time Frame: through 5 years post-implant
Baseline (pre-implant) T90 compared to T90 after implant (collected and reported at annual study visits). T90 is defined as the total sleep time spent with arterial oxygen saturation (SaO2) < 90%. A lower T90 indicates less severe sleep apnea.
through 5 years post-implant
Evaluation of improvement of Epworth Sleepiness Scale (ESS) over time
Time Frame: through 5 years post-implant
Baseline (pre-implant) Epworth Sleepiness Scale (ESS) compared to ESS after implant (collected and reported at annual study visits). The Epworth Sleepiness Scale is a validated, self-report instrument that rates a subject's tendency to fall asleep in eight common daily situations. Scores range from 0 to 24, with a lower score indicating less daytime sleepiness. An ESS score of 10 or less is equivalent to the normalized population.
through 5 years post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inspire Medical Systems, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2021

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

June 30, 2020

First Submitted That Met QC Criteria

June 30, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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