Evaluating the upper airway in obstructive sleep apnea using drug-induced sleep endoscopy
Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea
This study is testing if a special sleep test using medication can help doctors better understand the airways of people with obstructive sleep apnea who are thinking about surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Santa Monica, California) |
| Trial ID | NCT00695214 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of drug-induced sleep endoscopy (DISE) to assess the upper airway in patients with obstructive sleep apnea (OSA) who are considering surgical treatment. It aims to evaluate the reliability of DISE and compare its findings with traditional imaging techniques like lateral cephalogram X-ray. The study also focuses on patients who have not responded to previous sleep apnea surgeries, examining the correlation between DISE findings and surgical outcomes. The intervention involves sedation with propofol to facilitate the endoscopic evaluation.
Who should consider this trial
Good fit: Ideal candidates are adult patients with obstructive sleep apnea who are considering surgical treatment.
Not a fit: Patients who are minors, pregnant, or have contraindications to propofol will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate assessments of airway obstruction in OSA patients, improving surgical outcomes.
How similar studies have performed: Previous studies have shown moderate to substantial reliability of DISE, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients with OSA considering surgical treatment Exclusion Criteria: * Minors * Pregnant women * Patients unable to provide informed consent in English themselves * Prisoners * Allergy to propofol, soybean oil, egg lecithin or glycerol * Other contraindication to use of propofol (decision of anesthesiologist or otolaryngologist.)
Where this trial is running
Santa Monica, California
- UCLA Santa Monica Medical Center — Santa Monica, California, United States (Recruiting)
Study contacts
- Principal investigator: Eric J Kezirian, MD, MPH — University of California, Los Angeles
- Study coordinator: Eric J Kezirian, MD, MPH
- Email: ekezirian@mednet.ucla.edu
- Phone: 4242596559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.