Obstructive Sleep Apnea (OSA)
Conditions
Keywords
Obstructive Sleep Apnea, OSA, Inspire, AHI
Brief summary
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.
Detailed description
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.
Interventions
DEVICEInspire® UAS System
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.
Sponsors
Inspire Medical Systems, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is at least 18 years of age; 2. 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; 3. 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). 4. Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation; 5. Subject is willing and able to return for follow-up visits, undergo sleep studies (including in-lab and at-home), and complete questionnaires related to the study; 6. Subject is willing and able to provide informed consent.
Exclusion criteria
1. 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); 2. 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; 3. Subject has any condition or procedure that has compromised neurological control of the upper airway; 4. Subject is unable or does not have the necessary assistance to operate the patient remote; 5. Subject is pregnant or plans to become pregnant; 6. Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System; 7. Subject has a terminal illness with life expectancy \< 12 months; 8. Any other reason the investigator deems the subject is unfit for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Procedure and/or Device Related Adverse Events (Safety and Tolerability) | 5 years post-implant | Procedure-related Adverse Events; Device-related Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Apnea Hypopnea Index Over Time | 5 years post-implant | 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 | 5 years post-implant | Body Mass Index will be collected at each yearly follow-up visit. |
| Change in Oxygen Desaturation Index (ODI) Over Time | 5 years post-implant | 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 | 5 years post-implant | 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) |
| Change in Epworth Sleepiness Scale (ESS) Over Time | 5 years post-implant | 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) |
Countries
United States
Contacts
CONTACTGwen Gimmestad
Outcome results
None listed