Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea
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| ClinicalTrials.gov Identifier: NCT00695214 |
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Recruitment Status :
Recruiting
First Posted : June 11, 2008
Last Update Posted : May 6, 2019
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Sponsor:
University of Southern California
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
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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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 800 participants |
| 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
Genetics Home Reference related topics:
Obstructive sleep apnea
Drug Information available for:
Propofol
| Arm | Intervention/treatment |
|---|---|
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1
OSA Patients considering surgical treatment
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Drug: Propofol sedation
Patients receive an intravenous propofol infusion titrated to reach a target level of sedation, sleep with arousability to verbal stimuli. |
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 ]
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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.)
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
| Contact: Eric J Kezirian, MD, MPH | 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 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
| Principal Investigator: | Eric J Kezirian, MD, MPH | University of Southern California |
Publications of Results:
Other 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 |
| 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:
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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 |