Pediatric Post-Approval Registry
- Conditions
- Obstructive Sleep Apnea
- Registration Number
- NCT04457154
- Lead Sponsor
- Inspire Medical Systems, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria:<br><br> 1. Subject is between 18 and 21 years of age;<br><br> 2. Subject has a diagnosis of moderate to severe OSA (15 = AHI = 65) based on a recent<br> sleep study;<br><br> 3. Subject has documented failure of, or intolerance to, positive airway pressure<br> treatments, despite attempts to improve compliance;<br><br> 4. Subject is contraindicated for, or not effectively treated by, adenotonsillectomy;<br><br> 5. Subject has followed standard of care in considering all other alternative/adjunct<br> therapies;<br><br> 6. Subject is willing and able to have stimulation hardware permanently implanted and<br> to use the patient remote to activate the stimulation;<br><br> 7. Subject is willing and able to return for follow-up visits, undergo sleep studies<br> (including in-lab and at-home), and complete questionnaires related to the registry;<br><br> 8. Subject is willing and able to provide informed consent.<br><br>Exclusion Criteria:<br><br> 1. Subject has a combination of central + mixed apneas > 25% of the total<br> apnea-hypopnea index (AHI);<br><br> 2. Subject has any anatomical finding that would compromise the performance of upper<br> airway stimulation, such as the presence of complete concentric collapse of the soft<br> palate;<br><br> 3. Subject has any condition or procedure that has compromised neurological control of<br> the upper airway;<br><br> 4. Subject is unable, or does not have the necessary assistance, to operate the patient<br> remote;<br><br> 5. Subject is pregnant or plans to become pregnant;<br><br> 6. Subject has an implantable device that may be susceptible to unintended interaction<br> with the Inspire System;<br><br> 7. Subject has a terminal illness with life expectancy < 12 months;<br><br> 8. Any other reason the investigator deems the subject is unfit for participation in<br> the registry.
Not provided
Study & Design
- Study Type
- Observational [Patient Registry]
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of device and/or procedure related adverse events over time;Evaluation of the improvement of Apnea Hypopnea Index (AHI) over time
- Secondary Outcome Measures
Name Time Method Evaluation of improvement in Oxygen Desaturation Index (ODI) over time;Evaluation of improvement in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) < 90%) over time;Evaluation of improvement of Epworth Sleepiness Scale (ESS) over time