Magnetic Resonance Imaging in Obstructive Sleep Apnea

Withdrawn

• Conditions: Obstructive Sleep Apnea
• Interventions: Procedure: MRI, DISE, and Surgery

• Registration Number: NCT02207127
• Lead Sponsor: University of Southern California

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-07-31
• Study First Posted: 2014-08-01
• Status Verified: 2023-05
• Study Start: 2023-05-08
• Primary Completion: 2023-05-08
• Study Completion: 2023-05-08
• Last Update Submitted: 2023-08-08
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Read More

Exclusion Criteria

• 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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MRI, DISE, and Surgery	MRI, DISE, and Surgery	All participants will undergo MRI and DISE prior to undergoing surgical treatment of obstructive sleep apnea.

Primary Outcome Measures

Name	Time	Method
Surgical results	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.

Secondary Outcome Measures

Name	Time	Method
Sleep-Related Quality of Life	6 months	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.
Daytime Sleepiness	6 months	Daytime sleepiness will be assessed with the Epworth Sleepiness Scale score. Changes will be determined by a comparison of preoperative and postoperative scores.

Trial Locations

Locations (1)

Keck Hospital of USC; 🇺🇸 Los Angeles, California, United States