NCT00695214 Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea
| NCT ID | NCT00695214 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, Los Angeles |
| Condition | Sleep Apnea, Obstructive |
| Study Type | INTERVENTIONAL |
| Enrollment | 800 participants |
| Start Date | 2004-02 |
| Primary Completion | 2035-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 800 participants in total. It began in 2004-02 with a primary completion date of 2035-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.)
Contact & Investigator
Eric J Kezirian, MD, MPH
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT00695214 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sleep Apnea, Obstructive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT00695214 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT00695214 currently recruiting?
Yes, NCT00695214 is actively recruiting participants. Contact the research team at ekezirian@mednet.ucla.edu for enrollment information.
Where is the NCT00695214 trial being conducted?
This trial is being conducted at Santa Monica, United States.
Who is sponsoring the NCT00695214 clinical trial?
NCT00695214 is sponsored by University of California, Los Angeles. The principal investigator is Eric J Kezirian, MD, MPH at University of California, Los Angeles. The trial plans to enroll 800 participants.