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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02207127
Recruitment Status : Withdrawn (Unable to refine study measurements/protocol adequately.)
First Posted : August 1, 2014
Last Update Posted : May 10, 2023
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Eric James Kezirian, MD, MPH, University of Southern California

Study Description
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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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Procedure: MRI, DISE, and Surgery

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetic Resonance Imaging in Obstructive Sleep Apnea
Estimated Study Start Date : July 2023
Estimated Primary Completion Date : June 2030
Estimated Study Completion Date : July 2030

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
MRI, DISE, and Surgery
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02207127


Locations
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United States, California
Keck Hospital of USC
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Institutes of Health (NIH)
More Information
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Responsible Party: Eric James Kezirian, MD, MPH, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT02207127    
Other Study ID Numbers: HS-14-00101
First Posted: August 1, 2014    Key Record Dates
Last Update Posted: May 10, 2023
Last Verified: May 2023
Keywords provided by Eric James Kezirian, MD, MPH, University of Southern California:
obstructive sleep apnea
sleep apnea
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases