RECRUITING

Pediatric Down Syndrome Post-Approval Study

Conditions

Pediatric Obstructive Sleep Apnea Down Syndrome (DS)Pediatrics OSA Down Syndrome Pediatrics OSA Obstructive Sleep Apnea Long-term follow-up Post Approval Study PAS

Quick Navigation

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

The purpose of this Post Approval research study is to assess ongoing safety and effectiveness of the Inspire therapy in adolescents and young adults (age 13-18) with Down syndrome and severe sleep apnea. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatric Down syndrome population.

Official Title

Pediatric Down Syndrome Post-Approval Study

Quick Facts

Study Start:2025-02

Study Completion:2030-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06851338

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:13 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Patient has been diagnosed with Down syndrome; 2. Patient is 13-18 years of age; 3. Patient has been diagnosed with severe obstructive sleep apnea, with an AHI of ≥ 10 and ≤ 50 based on a recent (within 6 months of enrollment) qualified in-lab sleep study (PSG); 4. Patient has documented failure of, or intolerance to, positive airway pressure therapies (such as CPAP or BiPAP) despite attempts to improve compliance; 5. Patient is contraindicated for, or not effectively treated by, adenotonsillectomy; 6. Treatment of patient's OSA has followed standard of care in considering all other alternative/adjunctive therapies; 7. Patient, and their parents/guardians, is willing to have stimulation hardware permanently implanted, and be willing to participate in follow-up visits, postoperative in-lab sleep studies (PSGs), and questionnaire completion.	1. Patient's recent PSG (within 6 months of enrollment) reports central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI); 2. Patient 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. Patient has any condition or procedure that has compromised neurological control of the upper airway; 4. Patient, or their parent/guardian, is unable or does not have the necessary assistance to operate the patient remote; 5. Patient is pregnant or plans to become pregnant; 6. Patient has an implantable device that may be susceptible to unintended interaction with the Inspire system; 7. Patient will require magnetic resonance imaging (MRI) other than what is specified in the MR conditional labeling; 8. Patient has a terminal illness with life expectancy of less than 12 months; 9. Any other reason the investigator deems the patient is unfit for participation in the study.

Inclusion Criteria

Exclusion Criteria

1. Patient has been diagnosed with Down syndrome;
2. Patient is 13-18 years of age;
3. Patient has been diagnosed with severe obstructive sleep apnea, with an AHI of ≥ 10 and ≤ 50 based on a recent (within 6 months of enrollment) qualified in-lab sleep study (PSG);
4. Patient has documented failure of, or intolerance to, positive airway pressure therapies (such as CPAP or BiPAP) despite attempts to improve compliance;
5. Patient is contraindicated for, or not effectively treated by, adenotonsillectomy;
6. Treatment of patient's OSA has followed standard of care in considering all other alternative/adjunctive therapies;
7. Patient, and their parents/guardians, is willing to have stimulation hardware permanently implanted, and be willing to participate in follow-up visits, postoperative in-lab sleep studies (PSGs), and questionnaire completion.

1. Patient's recent PSG (within 6 months of enrollment) reports central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI);
2. Patient 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. Patient has any condition or procedure that has compromised neurological control of the upper airway;
4. Patient, or their parent/guardian, is unable or does not have the necessary assistance to operate the patient remote;
5. Patient is pregnant or plans to become pregnant;
6. Patient has an implantable device that may be susceptible to unintended interaction with the Inspire system;
7. Patient will require magnetic resonance imaging (MRI) other than what is specified in the MR conditional labeling;
8. Patient has a terminal illness with life expectancy of less than 12 months;
9. Any other reason the investigator deems the patient is unfit for participation in the study.

Contacts and Locations

Study Contact

Angela Chapin, Sr. Clinical Study Manager

CONTACT

763.392.7222

angelachapin@inspiresleep.com

Gwen Gimmestad, VP Clinical

CONTACT

763.392.9966

gwengimmestad@inspiresleep.com

Study Locations (Sites)

Phoenix Children's Hospital

Phoenix, Arizona, 85016

United States

Children's Hospital Orange County

Orange, California, 92868

United States

University of South Florida Morsani College of Medicine

Tampa, Florida, 33602

United States

Northwell Cohen Children's Hospital

Queens, New York, 11040

United States

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

Baylor College of Medicine/ Texas Children's Hospital

Houston, Texas, 77030

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 Date2025-02

Study Completion Date2030-05

Study Record Updates

Study Start Date2025-02

Study Completion Date2030-05

Terms related to this study

Keywords Provided by Researchers

Pediatrics
OSA
Down Syndrome
Pediatrics OSA
Obstructive Sleep Apnea
Long-term follow-up
Post Approval Study
PAS

Additional Relevant MeSH Terms

Pediatric Obstructive Sleep Apnea
Down Syndrome (DS)