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

Primary Purpose

Sleep Apnea, Obstructive

Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Propofol sedation
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Obstructive Sleep Apnea, Propofol, Sleep Endoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • UCLA Santa Monica Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

OSA Patients considering surgical treatment

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
June 4, 2008
Last Updated
June 9, 2023
Sponsor
University of California, Los Angeles
Collaborators
National Institutes of Health (NIH), American Academy of Otolaryngology-Head and Neck Surgery Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00695214
Brief Title
Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea
Official Title
Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Suspended
Why Stopped
Transfer to another institution
Study Start Date
February 2004 (Actual)
Primary Completion Date
June 2030 (Anticipated)
Study Completion Date
June 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institutes of Health (NIH), American Academy of Otolaryngology-Head and Neck Surgery Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Obstructive Sleep Apnea, Propofol, Sleep Endoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
OSA Patients considering surgical treatment
Intervention Type
Drug
Intervention Name(s)
Propofol sedation
Intervention Description
Patients receive an intravenous propofol infusion titrated to reach a target level of sedation, sleep with arousability to verbal stimuli.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric J Kezirian, MD, MPH
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Santa Monica Medical Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90401
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20403857
Citation
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.
Results Reference
background
PubMed Identifier
19393404
Citation
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.
Results Reference
result
PubMed Identifier
21557231
Citation
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.
Results Reference
result
PubMed Identifier
21614467
Citation
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.
Results Reference
result
PubMed Identifier
23086863
Citation
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.
Results Reference
result

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

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