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Neurostimulation Device
Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry
Chesterfield, MO
N/A
Waitlist Available
Research Sponsored by Inspire Medical Systems, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 12 months
Awards & highlights
No Placebo-Only Group
Summary
Inspire intends to conduct this registry to: 1) collect Inspire therapy clinical evidence in the clinical practice setting; 2) collect additional information on the effectiveness, use and safety in the commercial setting; and 3) engage physician customers to report the collective outcome within a group of properly trained programs that utilize Inspire therapy on a regular basis. In addition, a sub-study will be conducted under this Registry at a limited number of Registry centers and will include a cohort of Registry patients and a cohort of patients who have not received the Inspire therapy device due to denial of insurance coverage. The two sub-study cohorts' quality of life and AHI data will be compared.
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Eligible Conditions
- Obstructive Sleep Apnea
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Apnea Hypopnea (AHI) from Baseline to 12-Months
Change in Epworth Sleepiness Scale (ESS) from Baseline to 12 Months
Secondary study objectives
Advance or Additional Titrations
Clinical Global Impression (CGI-I)
Device Data Collection
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: CONTROLExperimental Treatment1 Intervention
This group will include 100 patients who have been denied insurance coverage of the Inspire therapy system implant by their provider, have had no intervention (Inspire), and are willing to complete a HSAT and provide information about their OSA treatment after denial.
Group II: ADHEREExperimental Treatment1 Intervention
This group will include 250 patients who have been implanted with the Inspire therapy system, enrolled in the ADHERE Registry, and are willing to complete a follow-up home sleep apnea test (HSAT).
Find a Location
Closest Location:Ohio State University· Columbus, OH· 3 miles
Who is running the clinical trial?
Inspire Medical Systems, Inc.Lead Sponsor
13 Previous Clinical Trials
1,792 Total Patients Enrolled
Gwen GimmestadStudy DirectorInspire Medical Systems, Inc.
1 Previous Clinical Trials
127 Total Patients Enrolled