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Magnetic Resonance Imaging in Obstructive Sleep Apnea

Magnetic Resonance Imaging in Obstructive Sleep Apnea

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02207127
Acronym
MRI in OSA
Enrollment
0
Registered
2014-08-01
Start date
2023-05-08
Completion date
2023-05-08
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea, sleep apnea

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.

Interventions

PROCEDUREMRI, DISE, and Surgery

MRI, DISE, and Surgery

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
University of Southern California
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Surgical results6 monthsSurgical 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

MeasureTime frameDescription
Sleep-Related Quality of Life6 monthsSleep-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 Sleepiness6 monthsDaytime sleepiness will be assessed with the Epworth Sleepiness Scale score. Changes will be determined by a comparison of preoperative and postoperative scores.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026