RECRUITING

Pediatric Post-Approval Registry

Conditions

Obstructive Sleep Apnea Pediatric Apnea-hypopnea Index Sleep Breathing Disorders

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Inspire Pediatric Post-Approval Registry

Quick Facts

Study Start:2021-11-30

Study Completion:2028-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04457154

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.

Ages Eligible for Study:18 Years to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Gwen Gimmestad

CONTACT

763-392-9966

gwengimmestad@inspiresleep.com

Mike Swierzewski, MS

CONTACT

michael.swierzewski@inspiresleep.com

Study Locations (Sites)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329

United States

Duke University

Durham, North Carolina, 27705

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19406

United States

Children's Hospital of Pittsburgh

Sewickley, Pennsylvania, 15143

United States

University of Texas Southwestern/Children's Hospital of Dallas

Dallas, Texas, 75207

United States

Children's Hospital of the King's Daughters/East Virginia Medical School

Norfolk, Virginia, 23507

United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2021-11-30

Study Completion Date2028-04

Study Record Updates

Study Start Date2021-11-30

Study Completion Date2028-04

Terms related to this study

Keywords Provided by Researchers

Pediatric
Apnea-hypopnea Index
Sleep Breathing Disorders

Additional Relevant MeSH Terms

Obstructive Sleep Apnea