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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00695214
Enrollment
800
Registered
2008-06-11
Start date
2004-02-01
Completion date
2035-06-01
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea, Obstructive

Keywords

Obstructive Sleep Apnea, Propofol, Sleep Endoscopy

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.

Interventions

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

Sponsors

University of California, Los Angeles
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
American Academy of Otolaryngology-Head and Neck Surgery Foundation
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.)

Design outcomes

Primary

MeasureTime 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 outcomesPreoperative and postoperative

Countries

United States

Contacts

CONTACTEric J Kezirian, MD, MPH
ekezirian@mednet.ucla.edu4242596559
PRINCIPAL_INVESTIGATOREric J Kezirian, MD, MPH

University of California, Los Angeles

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026