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NCT Number: NCT00695214

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UCLA Santa Monica Medical Center

Santa Monica, California, 90401, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Propofol sedation

Drug

Patients receive an intravenous propofol infusion titrated to reach a target level of sedation, sleep with arousability to verbal stimuli.

Primary outcomes

  1. 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 outcomes

    Time frame: Preoperative and postoperative

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Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • American Academy of Otolaryngology-Head and Neck Surgery Foundation
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2004
Primary completion
2035
Study completion
2035
First posted
Jun 11, 2008
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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