- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00695214
Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea
June 9, 2023 updated by: Eric. J. Kezirian, MD, MPH, University of California, Los Angeles
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.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
800
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eric J Kezirian, MD, MPH
- Email: eric.kezirian@med.usc.edu
Study Locations
-
-
California
-
Santa Monica, California, United States, 90401
- UCLA Santa Monica Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1
OSA Patients considering surgical treatment
|
Patients receive an intravenous propofol infusion titrated to reach a target level of sedation, sleep with arousability to verbal stimuli.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Preoperative and postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Eric J Kezirian, MD, MPH, University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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):1233-1236. 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2004
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
June 1, 2030
Study Registration Dates
First Submitted
June 4, 2008
First Submitted That Met QC Criteria
June 10, 2008
First Posted (Estimated)
June 11, 2008
Study Record Updates
Last Update Posted (Estimated)
June 13, 2023
Last Update Submitted That Met QC Criteria
June 9, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Signs and Symptoms, Respiratory
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Apnea
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Hypnotics and Sedatives
- Propofol
Other Study ID Numbers
- HS-13-00379
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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