NCT00695214

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for phase_2

Timeline
50mo left

Started Feb 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Feb 2004Jun 2030

Study Start

First participant enrolled

February 1, 2004

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 11, 2008

Completed
22 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

26.3 years

First QC Date

June 4, 2008

Last Update Submit

July 24, 2025

Conditions

Sleep Apnea, Obstructive

Keywords

Obstructive Sleep ApneaPropofolSleep Endoscopy

Outcome Measures

Primary Outcomes (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

    Preoperative and postoperative

Study Arms (1)

1

OTHER

OSA Patients considering surgical treatment

Drug: Propofol sedation

Interventions

Propofol sedationDRUG

Patients receive an intravenous propofol infusion titrated to reach a target level of sedation, sleep with arousability to verbal stimuli.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with OSA considering surgical treatment

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Santa Monica Medical Center

Santa Monica, California, 90401, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 20403857BACKGROUND

  • 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.

    PMID: 19393404RESULT

  • 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.

    PMID: 21557231RESULT

  • 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.

    PMID: 21614467RESULT

  • 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.

    PMID: 23086863RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Eric J Kezirian, MD, MPH

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric J Kezirian, MD, MPH

CONTACT

4242596559ekezirian@mednet.ucla.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Head and Neck Surgery

Study Record Dates

First Submitted

June 4, 2008

First Posted

June 11, 2008

Study Start

February 1, 2004

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2030

Last Updated

July 29, 2025

Record last verified: 2025-07

Locations

US(1)