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.
Subject is at least 18 years of age;
Subject has a diagnosis of severe OSA (65 ≤ AHI ≤ 100) based on a recent sleep study (within 12 months) OR Subject has a diagnosis of moderate to severe OSA (15≤AHI≤100) AND a baseline Body Mass Index of 32<BMI≤40 kg/m2;
Subject has documented failure of, or intolerance to, positive airway pressure treatments (such as CPAP or BPAP machines; NOTE: PAP failure is defined as an inability to eliminate OSA (AHI > 15 despite PAP usage). PAP intolerance is defined as the inability to use PAP (> 5 nights per week, 4 hours of usage per night) or unwillingness to use PAP (e.g. patient returns the PAP system after attempting to use it).
Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;
Subject has a combination of central + mixed apneas > 25% of the total apnea-hypopnea index (AHI) based on a recent sleep study (within 12 months);
Subject 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;
Subject has any condition or procedure that has compromised neurological control of the upper airway;
Subject is unable or does not have the necessary assistance to operate the patient remote;
A post-market sample selected from enrolling center's real-world patient population
Case-control
Prospective
Inspire® UAS System
DeviceParticipants 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.
Incidence of Procedure and/or Device Related Adverse Events (Safety and Tolerability)
Procedure-related Adverse Events; Device-related Adverse Events
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)
Body Mass Index
Body Mass Index will be collected at each yearly follow-up visit.
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)
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)
Evaluation of Therapy Usage and Adherence Over Time
Therapy usage - reported as hours of use per week, is recorded by the Inspire UAS system and will be captured during the device check at the 6M and annual (1-5 year) study visits. This value will be used to quantify device use and adherence over time.
Change in Patient Satisfaction Over Time
A patient satisfaction survey, designed to collect information about the patient's experience with the Inspire UAS system, will be collected at the 6M and annual (1-5 year) study visits. This survey will provide information about relative satisfaction with the therapy over time.
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