Correlation Endoscopic View of Airway Obstruction With RRa in OSA Patients Under DEX Monitored With SedLine EEG
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ClinicalTrials.gov Identifier: NCT02639884 |
Recruitment Status :
Completed
First Posted : December 28, 2015
Last Update Posted : February 12, 2019
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Condition or disease | Intervention/treatment | Phase |
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Obstructive Sleep Apnea (OSA) | Device: SedLine EEG Device: RRa monitoring | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 51 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Correlation of Endoscopic View of Airway Obstruction With RRa Signal in OSA Patients Under Dexmedetomidine Anesthesia Monitored With SedLine EEG |
Study Start Date : | December 2015 |
Actual Primary Completion Date : | October 2017 |
Actual Study Completion Date : | October 2017 |

Arm | Intervention/treatment |
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Experimental: Evaluation Group
All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring
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Device: SedLine EEG Device: RRa monitoring |
- electroencephalogram (EEG) signals [ Time Frame: up to 24 weeks. ]
- Acoustic Respiratory Rate (RRa) signals [ Time Frame: up to 24 weeks. ]

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Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult patients more than 18 years old with American Society of Anesthesiologists (ASA) classification of I, II, or III.
- Patients undergoing sedation for sleep endoscopy with DEX alone, and possible surgical follow-up.
Exclusion Criteria:
- ASA classification higher than III.
- Any deformities or diseases that may prevent application of SedLine (Masimo Sedation Monitoring) or RAM (Masimo Rainbow Acoustic Monitoring) sensors with a proper fit
- Inability to obtain any physiological, vital, demographics and real time anaesthesia data
- Subjects who have known intolerance to any of the drugs to be used according to the study protocol
- Subjects deemed not suitable for study at the discretion of the Principal Investigator.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639884
United States, California | |
Stanford University Medical Center | |
Stanford, California, United States, 94305 |
Principal Investigator: | David R Drover, M.D. | Stanford University |
Responsible Party: | Masimo Corporation |
ClinicalTrials.gov Identifier: | NCT02639884 |
Other Study ID Numbers: |
DROV0007 |
First Posted: | December 28, 2015 Key Record Dates |
Last Update Posted: | February 12, 2019 |
Last Verified: | February 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Sleep Apnea, Obstructive Airway Obstruction Sleep Apnea Syndromes Apnea Respiration Disorders Respiratory Tract Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Respiratory Insufficiency |