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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\
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High AHI | Following patients with 65\ |
| |
| High BMI | Following patients with 32\ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspire® UAS System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Procedure and/or Device Related Adverse Events (Safety and Tolerability) | Procedure-related Adverse Events; Device-related Adverse Events | 5 years post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 5 years post-implant |
| Body Mass Index |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years post-implant |
Inclusion Criteria:
Exclusion Criteria:
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A post-market sample selected from enrolling center's real-world patient population
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gwen Gimmestad | Contact | 763-392-9966 | gwengimmestad@inspiresleep.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado ENT & Allergy | Recruiting | Colorado Springs | Colorado | 80923 | United States |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Body Mass Index will be collected at each yearly follow-up visit. |
| 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) | 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) | 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) | 5 years post-implant |
| 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. |
| 5 years post-implant |
| Florida Sleep Specialists | Recruiting | Bradenton | Florida | 34209 | United States |
|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
|
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
|
| University of Rochester | Recruiting | Rochester | New York | 14642 | United States |
|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |