Magnetic Resonance Imaging in Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

— MRI in OSA  

Official title:

Magnetic Resonance Imaging in Obstructive Sleep Apnea

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02207127
• Other study ID #: HS-14-00101
• Status: Withdrawn
• Start date: May 8, 2023
• Est. completion date: May 8, 2023

Study information

• Verified date: May 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 8, 2023
• Est. primary completion date: May 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• MRI, DISE, and Surgery
MRI, DISE, and Surgery

Locations

Country	Name	City	State
United States	Keck Hospital of USC	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical results	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.	6 months
Secondary	Sleep-Related Quality of Life	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.	6 months
Secondary	Daytime Sleepiness	Daytime sleepiness will be assessed with the Epworth Sleepiness Scale score. Changes will be determined by a comparison of preoperative and postoperative scores.	6 months