Magnetic Resonance Imaging in Obstructive Sleep Apnea (MRI in OSA)
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|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Recruitment Status : Withdrawn (Unable to refine study measurements/protocol adequately.)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
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|Condition or disease||Intervention/treatment|
|Obstructive Sleep Apnea||Procedure: MRI, DISE, and Surgery|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|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|
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
- 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.
- 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.
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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|
- age ≥ 21 years; moderate to severe OSA (AHI ≥15 events/hour)
- body mass index <40 kg/m2.
- 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.
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
|United States, California|
|Keck Hospital of USC|
|Los Angeles, California, United States, 90033|
|Responsible Party:||Eric James Kezirian, MD, MPH, Professor, University of Southern California|
|Other Study ID Numbers:||
|First Posted:||August 1, 2014 Key Record Dates|
|Last Update Posted:||May 10, 2023|
|Last Verified:||May 2023|
obstructive sleep apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases