Magnetic Resonance Imaging in Obstructive Sleep Apnea

NCT02207127 | Withdrawn

• 1 other identifier: HS-14-00101
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; sleep apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Sleep-Related Quality of Life

  6 months

• Daytime Sleepiness

  6 months

Study Arms (1)

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

Interventions

MRI, DISE, and Surgery PROCEDURE

MRI, DISE, and Surgery

MRI, DISE, and Surgery

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be adults with obstructive sleep apnea undergoing surgery. All participants will undergo magnetic resonance imaging (MRI) and drug-induced sleep endoscopy (DISE).

You may qualify if:

• age ≥ 21 years; moderate to severe OSA (AHI ≥15 events/hour)
• body mass index \<40 kg/m2.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Magnetic Resonance Spectroscopy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: August 1, 2014
• Study Start: May 8, 2023
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-05

Locations

US (1)