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

Phase 2RecruitingNCT00695214

University of California, Los Angeles800 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

800

Conditions

Sleep Apnea, Obstructive

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.)

Outcomes

Primary Outcomes

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