|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P130008 / PAS002 |
| Date Original Protocol Accepted |
04/30/2014
|
| Date Current Protocol Accepted |
09/11/2017
|
| Study Name |
New Enrollment Study
|
| Device Name |
INSPIRE II UPPER AIRWAY STIMULATOR
|
| Clinical Trial Number(s) |
NCT01161420
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of this study is to obtain additional long-term safety and effectiveness data on the use of Inspire therapy in a post-market setting. In addition, this study will evaluate physician training by collecting post-operative safety outcomes
|
| Study Population |
The study is being conducted in a post-market environment for the treatment of moderate to severe Obstructive Sleep Apnea (OSA) (15 less than or equal to AHI less than or equal to 65) in subjects who have been confirmed to fail or cannot tolerate positive airway pressure (PAP) treatments (such as continuous positive airway pressure [CPAP] or bi-level positive airway pressure [BPAP] machines) and who do not have a complete concentric collapse at the soft palate level.
|
| Sample Size |
127 patients. 10 sites for now. Since study initiation efforts began in March of 2015, 15 sites have been activated for enrollment in the study. Activated sites have IRB approval, contract/clinical study agreement in place, study team training completed, and additional site regulatory documents in place. Of the 15 activated sites, five have closed due to logistical or resource challenges.
|
| Key Study Endpoints |
Safety: There are three safety endpoints included in this study.
Long-term device-related serious adverse events (SAE): This safety endpoint will assess long-term (5 years) safety via comparison of device related SAEs with a performance goal. Device-related SAEs include device explants due to device-related infection, device malfunction, lead fracture, device or lead reposition that results in surgical intervention.
Therapy-specific adverse events at 12 months: This safety endpoint will evaluate the safety of the Inspire system in the treatment of sleep apnea by evaluating procedure- and device-related AEs occurring immediately postimplant through 12 months.
Long-term (5 years) therapy-related adverse events: This safety endpoint will assess long-term safety via the description of all reported AEs, including all therapy- and procedure-related events.
Evaluation of Performance of Newly Trained Physicians: This endpoint will assess the performance of newly trained physician and will collect surgical times, post-operative pain recovery, procedure-related AEs and post-operation comments.
Effectiveness: Effectiveness endpoints will use disease-specific quality of life measures and OSA severity measures of ODI and AHI. Therapy effectiveness will be measured by the Epworth Sleepiness Scale (ESS) and the Functional Outcome of Sleep Questionnaire (FOSQ) quality of life questionnaires annually out to 5 years. Therapy effectiveness as measured by the apnea
hypopnea index (AHI) and the oxygen desaturation index (ODI) using a single in-lab PSG or two-night home sleep test at 3 years.
Epworth Sleepiness Scale (ESS) at 12 months: The ESS is a validated quality of life instrument that rates a subject’s daytime sleepiness.
The objective of this endpoint is to demonstrate an improvement at 12 months as compared to baseline
Functional Outcomes of Sleep Questionnaire (FOSQ) at 12 months: The FOSQ is a validated quality of life instrument that assesses the effect of a subject’s daytime sleepiness on activities of ordinary living. The objective of this endpoint is to demonstrate an improvement at 12 months as compared to baseline.
Oxygen Desaturation Index (ODI): Oxygen Desaturation Index (ODI) is a measure of OSA severity and is commonly used in the clinical evaluation of management of OSA. The ODI endpoint in this study will be determined by the ODI score at the 3-year follow up as compared to baseline. The objective is to demonstrate improvement at 3 years as compared to baseline.
Apnea Hypopnea Index (AHI). Apnea Hypopnea Index (AHI) is a measure of OSA severity. The objective of this endpoint
is to demonstrate an improvement of OSA severity at 3 years as compared to baseline.
|
| Follow-up Visits and Length of Follow-up |
5 years post-implant
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
127
|
| Actual Number of Sites Enrolled |
7
|
| Patient Follow-up Rate |
Table 2: Total enrolled-206, Screen failures-79, Implanrewd-127, Early exit-42 and Completed study-62
|
| Final Safety Findings |
Adverse events: SAE-73, Procedure related-2, Device/Therapy related-20, NSAE-253:Procedure related-60, Device/ Therapy related 115 (N=127)
|
| Final Effect Findings |
ESS: The median ESS score at 12 months was 6 with confidence interval of 5.5-8.5. The score was significantly less than 10. FOSQ: As improvement is defined as an increase in totals FOSQ score of 2 points. The mean change in FOSQ score from baseline to 12 months was 1.9 with confidence intervals of 1.38-3.AHI and ODI: The median change in AHI from baseline to 3 years was 16.7. The median change in ODI from baseline to 3 years was 8 ( Mean change 7.81-+/-16.25)
|
