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Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea

Phase 2
Recruiting
Conditions
Sleep Apnea, Obstructive
Interventions
Registration Number
NCT00695214
Lead Sponsor
University of California, Los Angeles
Brief Summary

Prospective, interventional cohort study of drug-induced sleep endoscopy (DISE) to evaluate the upper airway in a cohort of obstructive sleep apnea (OSA) surgical patients. This study has investigated the reliability of this technique, demonstrating moderate-substantial interrater and test-retest reliability. This research has also compared DISE findings to those of the lateral cephalogram X-ray and examined DISE findings in individuals who have not responded to previous sleep apnea surgery. These papers have been published and available through PubMed. Additional research is ongoing, with examination of DISE findings, comparison to other evaluation techniques, and the association between DISE findings and surgical outcomes.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
800
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.)

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1Propofol sedationOSA Patients considering surgical treatment
Primary Outcome Measures
NameTimeMethod
Association between DISE and physical examination; between DISE and polysomnogram results; between DISE and awake Mueller maneuver; between DISE and lateral cephalometry; and between DISE findings and surgical outcomesPreoperative and postoperative
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

UCLA Santa Monica Medical Center

🇺🇸

Santa Monica, California, United States

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