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

This study is currently recruiting participants.
Verified October 2016 by Eric Kezirian, University of Southern California
Sponsor:
ClinicalTrials.gov Identifier:
NCT02207127
First Posted: August 1, 2014
Last Update Posted: October 26, 2016
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.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Eric Kezirian, University of Southern California
  Purpose
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 Intervention
Obstructive Sleep Apnea Procedure: MRI, DISE, and Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetic Resonance Imaging in Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Eric Kezirian, University of Southern California:

Primary Outcome Measures:
  • 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:
  • 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.


Estimated Enrollment: 40
Study Start Date: July 2014
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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
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


Contacts
Contact: Eric J Kezirian, MD, MPH eric.kezirian@med.usc.edu

Locations
United States, California
Keck Hospital of USC Recruiting
Los Angeles, California, United States, 90033
Contact: Eric J Kezirian, MD, MPH       eric.kezirian@med.usc.edu   
Principal Investigator: Eric J Kezirian, MD, MPH         
Sponsors and Collaborators
University of Southern California
National Institutes of Health (NIH)
  More Information

Responsible Party: Eric Kezirian, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT02207127     History of Changes
Other Study ID Numbers: HS-14-00101
First Submitted: July 29, 2014
First Posted: August 1, 2014
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Eric Kezirian, University of Southern California:
obstructive sleep apnea
sleep apnea

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases