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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Adult patients with OSA considering surgical treatment

Disqualifiers

Minors

Pregnant women

Patients unable to provide informed consent in English themselves

Prisoners

Trial design

Design model

Single group

Treatments tested in this trial

  • Propofol sedation

    Drug

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

Treatment groups

800 Participants
are divided into 1 treatment group
Group A: 1Other 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Preoperative and postoperative

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

National Institutes of Health (NIH)

Collaborator

American Academy of Otolaryngology-Head and Neck Surgery Foundation

Collaborator