The purpose of this observational clinical study is to provide evaluation of long-term safety and effectiveness in a newly expanded patient population including patients with a higher AHI and a higher BMI.
This post-approval study is a condition of FDA approval and will collect long-term safety and effectiveness data on an expanded population that includes patients with very severe obstructive sleep apnea (65\<AHI≤100 events/hr), as well as those with a higher BMI (32\<BMI≤40 kg/m2). Participants will be implanted with a commercially available Inspire UAS System. In addition, participants will receive a patient remote which is used to initiate therapy each night.
Study Type
OBSERVATIONAL
Enrollment
70
Participants will be implanted with a commercially available Inspire® UAS System. In addition, participants will receive a patient remote which is used to initiate therapy each night.
Colorado ENT & Allergy
Colorado Springs, Colorado, United States
NOT_YET_RECRUITINGFlorida Sleep Specialists
Bradenton, Florida, United States
RECRUITINGRush University Medical Center
Chicago, Illinois, United States
Incidence of Procedure and/or Device Related Adverse Events (Safety and Tolerability)
Procedure-related Adverse Events; Device-related Adverse Events
Time frame: 5 years post-implant
Change in Apnea Hypopnea Index Over Time
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)
Time frame: 5 years post-implant
Body Mass Index
Body Mass Index will be collected at each yearly follow-up visit.
Time frame: 5 years post-implant
Change in Oxygen Desaturation Index (ODI) Over Time
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)
Time frame: 5 years post-implant
Change in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) < 90%) Over Time
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)
Time frame: 5 years post-implant
Change in Epworth Sleepiness Scale (ESS) Over Time
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)
Time frame: 5 years post-implant
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University of Kansas Medical Center
Kansas City, Kansas, United States
RECRUITINGUniversity of Rochester
Rochester, New York, United States
RECRUITING