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| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P130008 S089/ PAS001 |
| Date Original Protocol Accepted |
05/19/2023
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| Date Current Protocol Accepted |
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| Study Name |
Inspire UAS New Enrollment PAS
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| Device Name |
Inspire Upper Airway Stimulation
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adolescent: 13-18 yrs,
Transit. Adolescent A (distinctively) : 18-21 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
This study is a prospective, multi-center, single-arm study of pediatric subjects (age 13-18) with Down syndrome who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) system for the treatment of severe obstructive sleep apnea (OSA). Subjects will be followed for five (5) years post-implant.
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.
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| Study Population |
Subjects will be recruited in accordance with the approved indications for use and study eligibility criteria which includes:
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 greater than or equal to 10 and less than or equal to 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 must be willing to have stimulation hardware permanently implanted, and be willing to participate in follow-up visits, postoperative in-lab PSG sleep studies, and questionnaire completion.
Exclusion Criteria:
8. Patient’s recent PSG (within 6 months of enrollment) reported central + mixed apneas > 25% of the total apnea-hypopnea index (AHI);
9. 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;
10. Patient has any condition or procedure that has compromised neurological control of the upper airway;
11. Patient and/or their parent/guardian is unable or does not have the necessary assistance to operate the patient remote;
12. Patient is pregnant or plans to become pregnant;
13. Patient has an implantable device that may be susceptible to unintended interaction with the Inspire System;
14. Patient will require magnetic resonance imaging (MRI) other than what is specified in the MR conditional labeling;
15. Patient has a terminal illness with life expectancy < 12 months;
16. Any other reason the investigator deems the subject is unfit for participation in the study.
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| Sample Size |
Number of subjects: 60
Assumptions for sample size estimation: as recommended by the FDA, A total of sixty (60) subjects, with even distribution across the age range, will be implanted at a minimum of five (5) clinical centers in the United States.
Number of sites: 5
Sites location: US
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| Key Study Endpoints |
Safety Endpoints
Primary: Evaluation of device and/or procedure-related adverse events
Secondary: None
Effectiveness Endpoints
Primary:
Evaluation of improvement in Apnea-Hypopnea Index (AHI)
Evaluation of improvement in Oxygen Desaturation Index (ODI)
Evaluation of improvement in T90
Secondary:
Evaluation of improvement in sleepiness symptoms using the ESS-CHAD
Evaluation of Inspire UAS compliance (therapy usage)
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| Follow-up Visits and Length of Follow-up |
Subjects will be enrolled in the study prior to implant. Data for each implanted subject will be collected at the following timepoints:
• Baseline
• Implant
• 1 Week Post-op
• Activation (1 Month Post-Implant)
• 2 Months Post-Implant
• 3 Months Post-Implant
• 4 Months Post-Implant
• 6 Months Post-Implant
• 1, 2, 3, 4, 5 Years Post-Implant
• Interim Visits (if applicable)
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