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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Drug: Propofol sedation Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea
Study Start Date : February 2004
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2030

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695214


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

Locations
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United States, California
Keck Medical Center of USC Recruiting
Los Angeles, California, United States, 90033
Contact: Eric J Kezirian, MD, MPH       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       eric.kezirian@med.usc.edu   
Principal Investigator: Eric Kezirian, MD, MPH         
Sponsors and Collaborators
University of Southern California
National Institutes of Health (NIH)
American Academy of Otolaryngology-Head and Neck Surgery Foundation
Investigators
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Principal Investigator: Eric J Kezirian, MD, MPH University of Southern California
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Eric Kezirian, Professor, Otolaryngology - Head & Neck Surgery, University of Southern California
ClinicalTrials.gov Identifier: NCT00695214    
Other Study ID Numbers: HS-13-00379
First Posted: June 11, 2008    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Keywords provided by Eric Kezirian, University of Southern California:
Obstructive Sleep Apnea
Propofol
Sleep Endoscopy
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics