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临床试验/NCT02207127
NCT02207127撤回不适用

Magnetic Resonance Imaging in Obstructive Sleep Apnea

University of Southern California1 个研究点 分布在 1 个国家开始时间: 2023年5月8日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Surgical results

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age ≥ 21 years; moderate to severe OSA (AHI ≥15 events/hour)
  • body mass index <40 kg/m2.

排除标准

  • prior OSA surgery
  • known neurologic, cardiac, pulmonary, renal, or hepatic disorders
  • psychiatric problems except for treated depression or mild anxiety
  • co-existing sleep disorder other than OSA
  • other contraindication to DISE or MRI such as propofol allergy.

结局指标

主要结局

Surgical results

时间窗: 6 months

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.

次要结局

  • Sleep-Related Quality of Life(6 months)
  • Daytime Sleepiness(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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