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Magnetic Resonance Imaging in Obstructive Sleep Apnea (MRI in OSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02207127
Recruitment Status : Recruiting
First Posted : August 1, 2014
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Eric Kezirian, University of Southern California

Tracking Information
First Submitted Date July 29, 2014
First Posted Date August 1, 2014
Last Update Posted Date May 6, 2019
Study Start Date July 2014
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 31, 2014)
Surgical results [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 31, 2014)
  • Sleep-Related Quality of Life [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Magnetic Resonance Imaging in Obstructive Sleep Apnea
Official Title Magnetic Resonance Imaging in Obstructive Sleep Apnea
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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).
Condition Obstructive Sleep Apnea
Intervention Procedure: MRI, DISE, and Surgery
Study Groups/Cohorts MRI, DISE, and Surgery
All participants will undergo MRI and DISE prior to undergoing surgical treatment of obstructive sleep apnea.
Intervention: Procedure: MRI, DISE, and Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 31, 2014)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2030
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Eric J Kezirian, MD, MPH eric.kezirian@med.usc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02207127
Other Study ID Numbers HS-14-00101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Eric Kezirian, University of Southern California
Study Sponsor University of Southern California
Collaborators National Institutes of Health (NIH)
Investigators Not Provided
PRS Account University of Southern California
Verification Date May 2019