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

Part of paid clinical trials in Santa Monica, California.

Sponsor
University of California, Los Angeles
Study ID
NCT00695214
Phase
PHASE2
Status
Recruiting

Conditions

  • Sleep Apnea, Obstructive

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 29, 2004
Status verified
Jul 2025
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
800 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: 1
    OSA Patients considering surgical treatment

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

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA Santa Monica Medical CenterSanta MonicaCalifornia90401
Eric Kezirian, MD, MPH
Eric Kezirian, MD, MPH (PRINCIPAL_INVESTIGATOR)

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