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New treatment option for Pediatric Obstructive Sleep Apnea
Official title Pediatric Down Syndrome Post-Approval Study
ClinicalTrials.gov ID: NCT06851338
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 18
You may be able to join if
- Patient has been diagnosed with Down syndrome;
- Patient is 13-18 years of age;
- 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)...
- Patient has documented failure of, or intolerance to, positive airway pressure therapies (such as CPAP or BiPAP) despite attempts to improve...
- Patient is contraindicated for, or not effectively treated by, adenotonsillectomy;
You likely can't join if
- Patient's recent PSG (within 6 months of enrollment) reports central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI);
- Patient has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric...
- Patient has any condition or procedure that has compromised neurological control of the upper airway;
- Patient, or their parent/guardian, is unable or does not have the necessary assistance to operate the patient remote;
- Patient is pregnant or plans to become pregnant;
- Patient has an implantable device that may be susceptible to unintended interaction with the Inspire system;
See the full eligibility criteria
- Patient has been diagnosed with Down syndrome;
- Patient is 13-18 years of age;
- 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);
- Patient has documented failure of, or intolerance to, positive airway pressure therapies (such as CPAP or BiPAP) despite attempts to improve compliance;
- Patient is contraindicated for, or not effectively treated by, adenotonsillectomy;
- Treatment of patient's OSA has followed standard of care in considering all other alternative/adjunctive therapies;
- 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...
- Patient's recent PSG (within 6 months of enrollment) reports central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI);
- 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;
- Patient has any condition or procedure that has compromised neurological control of the upper airway;
- Patient, or their parent/guardian, is unable or does not have the necessary assistance to operate the patient remote;
- Patient is pregnant or plans to become pregnant;
- Patient has an implantable device that may be susceptible to unintended interaction with the Inspire system;
- Patient will require magnetic resonance imaging (MRI) other than what is specified in the MR conditional labeling;
- Patient has a terminal illness with life expectancy of less than 12 months;
- Any other reason the investigator deems the patient is unfit for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Orange, California, United States
- Tampa, Florida, United States
- Queens, New York, United States
- Cleveland, Ohio, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Orange, California, United States; Tampa, Florida, United States; Queens, New York, United States; Cleveland, Ohio, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.