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

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00695214
• Other study ID #: HS-13-00379
• Status: Suspended
• Phase: Phase 2
• Start date: February 2004
• Est. completion date: June 2030

Study information

• Verified date: June 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.)

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	UCLA Santa Monica Medical Center	Santa Monica	California

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

References & Publications (5)

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

Outcome

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