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
|Condition or disease||Intervention/treatment|
|Obstructive Sleep Apnea||Procedure: MRI, DISE, and Surgery|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Magnetic Resonance Imaging in Obstructive Sleep Apnea|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||June 2022|
|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
- 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.
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
|Contact: Eric J Kezirian, MD, MPHemail@example.com|
|United States, California|
|Keck Hospital of USC||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Eric J Kezirian, MD, MPH firstname.lastname@example.org|
|Principal Investigator: Eric J Kezirian, MD, MPH|