Recruiting
Phase 2

Drug-Induced Sleep Endoscopy

Sponsor:

UCLA

Code:

NCT00695214

Conditions

Sleep Apnea, Obstructive

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Propofol sedation

Study Details

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.

Conditions

Sleep Apnea, Obstructive

Study ID

NCT00695214

Start date

Feb, 2004

Status verified date

Jun, 2026

Completion date

Jun, 2035

Anticipated

Primary completion date

Jun, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

800 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: 1

OSA Patients considering surgical treatment

Interventions

Propofol sedation

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Eric J Kezirian, MD, MPH

4242596559ekezirian@mednet.ucla.edu

Locations

UCLA Santa Monica Medical Center

Recruiting

Santa Monica, California, United States, 90401

Principal Investigator:

Eric Kezirian, MD, MPH

More Information

Sponsor

University of California, Los Angeles

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • Obstructive Sleep Apnea
  • Propofol
  • Sleep Endoscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-07-01.