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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00695214
Recruitment Status : Recruiting
First Posted : June 11, 2008
Last Update Posted : May 6, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
American Academy of Otolaryngology-Head and Neck Surgery Foundation
Information provided by (Responsible Party):
Eric Kezirian, University of Southern California

Tracking Information
First Submitted Date  ICMJE June 4, 2008
First Posted Date  ICMJE June 11, 2008
Last Update Posted Date May 6, 2019
Study Start Date  ICMJE February 2004
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00695214 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea
Official Title  ICMJE Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sleep Apnea, Obstructive
Intervention  ICMJE Drug: Propofol sedation
Patients receive an intravenous propofol infusion titrated to reach a target level of sedation, sleep with arousability to verbal stimuli.
Study Arms  ICMJE 1
OSA Patients considering surgical treatment
Intervention: Drug: Propofol sedation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 30, 2015)
800
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2008)
300
Estimated Study Completion Date  ICMJE June 2030
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eric J Kezirian, MD, MPH eric.kezirian@med.usc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00695214
Other Study ID Numbers  ICMJE HS-13-00379
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eric Kezirian, University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • American Academy of Otolaryngology-Head and Neck Surgery Foundation
Investigators  ICMJE
Principal Investigator: Eric J Kezirian, MD, MPH University of Southern California
PRS Account University of Southern California
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP