Trial record 19 of 583 for:
"Sleep Apnea, Obstructive"
Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea Surgery
This study is currently recruiting participants.
Verified May 2013 by University of California, San Francisco
Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
Eric Kezirian, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00695214
First received: June 4, 2008
Last updated: May 19, 2013
Last verified: May 2013
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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 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 and their association with surgical outcomes.
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Apnea, Obstructive |
Drug: Propofol sedation |
Phase 2 |
| 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 Surgery |
Resource links provided by NLM:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2004 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (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 |
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.)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00695214
Contacts
| Contact: Eric J Kezirian, MD, MPH | 415-353-2757 | ekezirian@ohns.ucsf.edu |
| Contact: Wendy Ma | 415-353-2870 | wma@ohns.ucsf.edu |
Locations
| 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 | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94115 | |
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Principal Investigator: | Eric J Kezirian, MD, MPH | University of California, San Francisco |
More Information
No publications provided by University of California, San Francisco
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | May 19, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
Obstructive Sleep Apnea Propofol Sleep Endoscopy |
Additional relevant MeSH terms:
|
Sleep Apnea, Obstructive Apnea Sleep Apnea Syndromes 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 |
ClinicalTrials.gov processed this record on May 21, 2013