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|
| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P130008 S090/ PAS001 |
| Date Original Protocol Accepted |
08/04/2023
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| Date Current Protocol Accepted |
|
| Study Name |
Inspire UAS High AHI/High BMI PAS
|
| Device Name |
Inspire Upper Airway Stimulation System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
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| Comparison Group |
Device Subjects Serve as Own Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This study is a prospective, multi-center, two-arm study of subjects with an Apnea-Hypopnea Index (AHI) > 65 and <= 100 events/hr and/or Body Mass Index (BMI) >32 and <= 40 kg/m2, who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of obstructive sleep apnea (OSA). Subjects will be followed for 5 years post-implant
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| Study Population |
Subjects will be recruited in accordance with the approved indication for use and will only include those subjects who are within the new AHI (65 < AHI <=100 events/hr) and BMI (32 < BMI<=40 kg/m2) ranges. Subjects will be considered enrolled at the time of informed consent. Implanted subjects must meet the study eligibility criteria and will be followed for 5 years post-implant. Those subjects that are enrolled but fail to meet the eligibility criteria will be considered screen failures.
Study arms:
AHI Cohort: Includes subjects with 65 < AHI<=100 events/hr
BMI Cohort: Includes subjects with 32 < BMI<=40 kg/m2
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| Sample Size |
Number of subjects: 70 implanted subjects - 35 implanted subjects in each arm
Assumptions for sample size estimation: NA
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 over time: relevant adverse events will be collected and reported through 5 years post-implant
Secondary: NA
Effectiveness Endpoints
Primary:
• Evaluation of improvement in Apnea Hypopnea Index (AHI) over time: baseline (pre-implant) AHI compared to AHI after implant (collected and reported at annual study visits)
• Evaluation of improvement in Oxygen Desaturation Index (ODI) over time: baseline (pre-implant) ODI compared to ODI after implant (collected and reported at annual study visits)
• Evaluation of improvement in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) < 90%) over time: baseline (pre-implant) T90 compared to T90 after implant (collected and reported at annual study visits)
• Evaluation of improvement of Epworth Sleepiness Scale (ESS) over time: baseline (pre-implant) ESS compared to ESS after implant (collected and reported at annual study visits)
Subjects enrolled in the BMI cohort will have their BMI monitored yearly throughout the study
Secondary: NA
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| Follow-up Visits and Length of Follow-up |
• Baseline
• Implant
• Activation (1 Month Post-Implant)
• 6 Months Post-implant
• 1, 2, 3, 4, 5 Years Post-Implant
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