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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02207127
Other study ID # HS-14-00101
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


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
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