NCT06851338 Pediatric Down Syndrome Post-Approval Study
| NCT ID | NCT06851338 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Inspire Medical Systems, Inc. |
| Condition | Pediatric Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-02 |
| Primary Completion | 2030-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-02 with a primary completion date of 2030-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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. Exclusion Criteria: 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06851338 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 18 Years, studying Pediatric Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06851338 currently recruiting?
Yes, NCT06851338 is actively recruiting participants. Contact the research team at angelachapin@inspiresleep.com for enrollment information.
Where is the NCT06851338 trial being conducted?
This trial is being conducted at Phoenix, United States, Orange, United States, Tampa, United States, Queens, United States and 2 additional locations.
Who is sponsoring the NCT06851338 clinical trial?
NCT06851338 is sponsored by Inspire Medical Systems, Inc.. The trial plans to enroll 60 participants.