Clinical trial NCT00695214: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Sleep Apnea, Obstructive
Keywords: Obstructive Sleep Apnea
Propofol
Sleep Endoscopy
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: American Academy of Otolaryngology-Head and Neck Surgery Foundation
First posted: 2008-06-11
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.)

Primary outcomes:
measure: 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
timeFrame: Preoperative and postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: UCLA Santa Monica Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Eric J Kezirian, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.