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

University of California, Los Angeles (UCLA)

Status and phase: Enrolling; Phase 2

Conditions: Sleep Apnea, Obstructive

Treatments: Drug: Propofol sedation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00695214

HS-13-00379

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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800 participants in 1 patient group

1

Other group

Description:

OSA Patients considering surgical treatment

Treatment:

Drug: Propofol sedation