Pediatric Post-Approval Registry

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.

Conditions

Obstructive Sleep Apnea

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Study Overview

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Study Details

Study overview

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.

Inspire Pediatric Post-Approval Registry

Pediatric Post-Approval Registry

Condition
Obstructive Sleep Apnea
Intervention / Treatment

-

Contacts and Locations

Atlanta

Children's Healthcare of Atlanta, Atlanta, Georgia, United States, 30329

Durham

Duke University, Durham, North Carolina, United States, 27705

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19406

Sewickley

Children's Hospital of Pittsburgh, Sewickley, Pennsylvania, United States, 15143

Dallas

University of Texas Southwestern/Children's Hospital of Dallas, Dallas, Texas, United States, 75207

Norfolk

Children's Hospital of the King's Daughters/East Virginia Medical School, Norfolk, Virginia, United States, 23507

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Inspire Medical Systems, Inc.,

Study Record Dates

2028-04