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

History of Changes

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:

MedlinePlus related topics: Endoscopy Sleep Apnea

Drug Information available for: Propofol

U.S. FDA Resources

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:

Rodriguez-Bruno K, Goldberg AN, McCulloch CE, Kezirian EJ. Test-retest reliability of drug-induced sleep endoscopy. Otolaryngol Head Neck Surg. 2009 May;140(5):646-51. doi: 10.1016/j.otohns.2009.01.012.

Kezirian EJ. Nonresponders to pharyngeal surgery for obstructive sleep apnea: insights from drug-induced sleep endoscopy. Laryngoscope. 2011 Jun;121(6):1320-6. doi: 10.1002/lary.21749. Epub 2011 May 6.

Kezirian EJ, Hohenhorst W, de Vries N. Drug-induced sleep endoscopy: the VOTE classification. Eur Arch Otorhinolaryngol. 2011 Aug;268(8):1233-6. doi: 10.1007/s00405-011-1633-8. Epub 2011 May 26.

George JR, Chung S, Nielsen I, Goldberg AN, Miller A, Kezirian EJ. Comparison of drug-induced sleep endoscopy and lateral cephalometry in obstructive sleep apnea. Laryngoscope. 2012 Nov;122(11):2600-5. doi: 10.1002/lary.23561. Epub 2012 Oct 19.

Kezirian EJ, White DP, Malhotra A, Ma W, McCulloch CE, Goldberg AN. Interrater reliability of drug-induced sleep endoscopy. Arch Otolaryngol Head Neck Surg. 2010 Apr;136(4):393-7. doi: 10.1001/archoto.2010.26.


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:


Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Dyssomnias Nervous System Diseases Respiration Disorders	Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Disorders Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on February 27, 2015

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