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Study Title Principal Investigator
Inspire Upper Airway Stimulation Post-FDA Approval Study
The purpose of this study is to obtain additional long-term safety and efficacy data on the use of the Inspire Upper Airway Stimulation System to treat obstructive sleep apnea.
Recruiting | Sleep Apnea | Not Multisite
Eric J. Kezirian, MD, MPH
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Magnetic Resonance Imaging in Obstructive Sleep Apnea
This is a study from a funded SC CTSI grant application. There is an existing IRB-approved protocol for a data repository for DISE. DISE is being performed as part of clinical care. MRI is performed for research purposes only. This submission is for the MRI component of the research study only, which is being performed for research purposes.There is a fundamental gap in our ability to design effective surgical treatment of obstructive sleep apnea (OSA) for the 30-40% of patients who cannot tolerate non-surgical treatment. OSA surgery outcomes vary widely, with the chances of a successful outcome ranging from 5% to 65% for individual or combination procedures. To predict and thereby to improve outcomes, we must determine what predicts surgical success. This project will compare findings from two evaluations: drug-induced sleep endoscopy (DISE) and upper airway magnetic resonance imaging (MRI). DISE has demonstrated important benefits, but it has important limitations. Upper airway MRI is the most complete evaluation performed during wakefulness, making it conducive to broad application and less expensive than DISE, but there are no studies utilizing MRI as a surgical evaluation. We propose a cross-sectional analysis of 50 adult subjects with moderate to severe OSA. In addition to history, physical examination, and polysomnogram (sleep study), all subjects will undergo DISE and MRI to characterize the pattern of obstruction. We will examine the association between DISE and MRI, focusing on specific DISE findings that have been associated with surgical outcomes. We are well-prepared for this innovative research and future NIH submissions because our multidisciplinary team has substantial expertise and experience in OSA investigation, DISE, and upper airway MRI.
Recruiting | Sleep Apnea | Not Multisite
Eric J. Kezirian, MD, MPH
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Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea
The purpose of this study is to create a data repository about drug-induced sleep endoscopy done in the context of clinical care. The purpose of this data collection is to improve the surgical evaluation of obstructive sleep apnea by examining the technique of drug-induced sleep endoscopy and its association with surgical outcomes. Traditional evaluation techniques are static during wakefulness, whereas drug-induced sleep endoscopy provides a dynamic evaluation under sleep-like conditions. This prospective cohort data collection study will evaluate drug-induced sleep endoscopy in adults with obstructive sleep apnea who are considering surgical treatment or who are undergoing surgical treatment of obstructive sleep apnea. Adults will undergo unconscious sedation in the operating room using intravenous propofol, and oOutcomes will include the distribution of findings, association with other evaluation techniques, and a comparison of drug-induced sleep endoscopy findings with surgical outcomes. Data collection will include All subjects will undergo history, physical examination, and sleep study before and after surgery. Statistical analyses will include a combination of t-tests, chi-squared tests, and regression analyses, as appropriate.
Recruiting | Sleep Apnea | Not Multisite
Eric J. Kezirian, MD, MPH
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