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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Southern California
Sponsor:
Collaborator:
National Institutes of Health, Triological Society, American Academy of Otolaryngology - Head and Neck Surgery
Information provided by (Responsible Party):
Eric Kezirian, University of Southern California
ClinicalTrials.gov Identifier:
NCT00695214
First received: June 4, 2008
Last updated: July 26, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Sleep Apnea, Obstructive
Drug: Propofol sedation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: February 2004
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
OSA Patients considering surgical treatment
Drug: Propofol sedation
Patients receive an intravenous propofol infusion titrated to reach a target level of sedation, sleep with arousability to verbal stimuli.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695214

Contacts
Contact: Eric J Kezirian, MD, MPH 323-442-5790 eric.kezirian@med.usc.edu

Locations
United States, California
Keck Medical Center of USC Recruiting
Los Angeles, California, United States, 90033
Contact: Eric J Kezirian, MD, MPH    323-442-5790    eric.kezirian@med.usc.edu   
University of Southern California, Dept. of Otolaryngology-Head & Neck Surgery Recruiting
Los Angeles, California, United States, 90033
Contact: Eric Kezirian, MD, MPH    323-442-5790    eric.kezirian@med.usc.edu   
Principal Investigator: Eric Kezirian, MD, MPH         
Sponsors and Collaborators
University of Southern California
National Institutes of Health, Triological Society, American Academy of Otolaryngology - Head and Neck Surgery
Investigators
Principal Investigator: Eric J Kezirian, MD, MPH University of Southern California
  More Information

Publications:
Responsible Party: Eric Kezirian, Professor, Otolaryngology - Head & Neck Surgery, University of Southern California
ClinicalTrials.gov Identifier: NCT00695214     History of Changes
Other Study ID Numbers: HS-13-00379
Study First Received: June 4, 2008
Last Updated: July 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
Obstructive Sleep Apnea
Propofol
Sleep Endoscopy

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Apnea
Sleep Apnea Syndromes
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic
Propofol
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014