Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea
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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 9, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sleep Apnea, Obstructive | Drug: Propofol sedation | Phase 2 |
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 |
Actual Study Start Date : | February 2004 |
Estimated Primary Completion Date : | June 2030 |
Estimated Study Completion Date : | June 2030 |

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. |
- 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 |
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.)

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
Contact: Eric J Kezirian, MD, MPH | eric.kezirian@med.usc.edu |
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 |
Principal Investigator: | Eric J Kezirian, MD, MPH | University of Southern California |
Other Publications:
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 9, 2022 |
Last Verified: | May 2022 |
Obstructive Sleep Apnea Propofol Sleep Endoscopy |
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory 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 |