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| Sponsor: | University of California, San Francisco |
|---|---|
| Information provided by (Responsible Party): | Eric Kezirian, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00695214 |
Purpose
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 is designed to investigate the feasibility and reliability of this technique, obtain additional information about upper airway behavior during sleep, and compare the DISE findings with other evaluation methods. We will consider the association between DISE findings and those of other popular techniques that aid in determining the pattern of airway obstruction in OSA: physical exam, polysomnogram results, awake fiberoptic laryngoscopy with Mueller maneuver and lateral cephalometry. Finally, we will evaluate the association between DISE findings and surgical outcomes. This study is designed to enhance the understanding of this technique of upper airway assessment in OSA patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Apnea, Obstructive |
Drug: Propofol sedation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea |
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2004 |
| Estimated Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
OSA Patients considering surgical treatment
|
Drug: Propofol sedation
Patients receive an intravenous propofol infusion titrated to reach a target level of sedation, sleep with arousability to verbal stimuli.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Eric Kezirian, MD, MPH | 415-353-2757 | ekezirian@ohns.ucsf.edu |
| Contact: Wendy Ma | 415-353-2870 | wma@ohns.ucsf.edu |
| United States, California | |
| University of California, San Francisco, Dept of Otolaryngology-HNS | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Eric Kezirian, MD, MPH 415-353-2757 ekezirian@ohns.ucsf.edu | |
| Contact: Wendy Ma 415-353-2870 wma@ohns.ucsf.edu | |
| Principal Investigator: Eric Kezirian, MD, MPH | |
| Principal Investigator: | Eric Kezirian, MD, MPH | University of California, San Francisco |
More Information
| Responsible Party: | Eric Kezirian, Associate Professor, Otolaryngology-Head and Neck, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00695214 History of Changes |
| Other Study ID Numbers: | H46945-24476-05 |
| Study First Received: | June 4, 2008 |
| Last Updated: | September 20, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Obstructive Sleep Apnea Propofol Sleep Endoscopy |
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
Propofol Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Hypnotics and Sedatives |
