An observational study in Obstructive Sleep Apnea, sponsored by University of Southern California. Withdrawn at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by University of Southern California · Observational
There is a fundamental gap in the investigators 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, the investigators 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. The investigators propose a cross-sectional analysis of 40 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. The investigators will examine the association between DISE and MRI, focusing on specific DISE findings that have been associated with surgical outcomes. The investigators multidisciplinary team has substantial expertise and experience in OSA investigation, DISE, and upper airway MRI.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
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Study participants will be adults with obstructive sleep apnea undergoing surgery. All participants will undergo magnetic resonance imaging (MRI) and drug-induced sleep endoscopy (DISE).
Exclusion Criteria:
All participants will undergo MRI and DISE prior to undergoing surgical treatment of obstructive sleep apnea.
Procedure: MRI, DISE, and Surgery
MRI, DISE, and Surgery
Surgical results
Surgical outcomes will be measured using sleep study outcomes (apnea-hypopnea index). The analysis will include evaluation of a potential association between surgical outcomes and both MRI and DISE measures.
Time frame: 6 months
Sleep-Related Quality of Life
Sleep-related quality of life will be assessed with the Functional Outcomes of Sleep Questionnaire. Changes will be determined by a comparison of preoperative and postoperative scores.
Time frame: 6 months
Daytime Sleepiness
Daytime sleepiness will be assessed with the Epworth Sleepiness Scale score. Changes will be determined by a comparison of preoperative and postoperative scores.
Time frame: 6 months
This study is withdrawn, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University of Southern California