Sleep Apnea, Obstructive Clinical Trial
Official title:
Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea
NCT number | NCT00695214 |
Other study ID # | HS-13-00379 |
Secondary ID | |
Status | Suspended |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | February 2004 |
Est. completion date | June 2030 |
Verified date | June 2023 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 800 |
Est. completion date | June 2030 |
Est. primary completion date | June 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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.) |
Country | Name | City | State |
---|---|---|---|
United States | UCLA Santa Monica Medical Center | Santa Monica | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | American Academy of Otolaryngology-Head and Neck Surgery Foundation, National Institutes of Health (NIH) |
United States,
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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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