Trial | NCT00695214  Report issue

Official Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Suspended

  • Intervention/Treatment

    propofol ...

  • Study Participants

    800
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 Started
Feb 29
2004
Primary Completion
Jun 30
2030
Anticipated
Study Completion
Jun 30
2030
Anticipated
Last Update
Jun 13
2023

Drug Propofol sedation

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

1 Other

OSA Patients considering surgical treatment

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.)
No Results Posted