Magnetic Resonance Imaging in Obstructive Sleep Apnea

NCT ID: NCT02207127

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-08
• Study Completion Date: 2023-05-08

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

MRI, DISE, and Surgery

All participants will undergo MRI and DISE prior to undergoing surgical treatment of obstructive sleep apnea.

MRI, DISE, and Surgery

Intervention Type: PROCEDURE

MRI, DISE, and Surgery

Interventions

MRI, DISE, and Surgery

MRI, DISE, and Surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Keck Hospital of USC

Los Angeles, California, United States

Countries

United States

Other Identifiers

HS-14-00101

Identifier Type: -

Identifier Source: org_study_id