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Patients with obstructive sleep apnea (OSA) could have several anatomical causes of obstruction. A sleep endoscopy study is a technique to help determine the anatomical cause of OSA. This study will be using standard of care practice and infuse dexmedetomidine (DEX) to induce sleep. The goals of the study are to (1) confirm airway obstruction with endoscopic view and correlate that with Acoustic Respiratory Rate (RRa) signal at the moment of airway obstruction, and (2) characterize the EEG signals when subjects are under DEX sedation alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluation Group | Experimental | All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SedLine EEG | Device |
| ||
| RRa monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects in Which Electroencephalogram (EEG) Signals is Collected | Subjects enrolled into the study will have the SedLine sensor placed on the subject to collect EEG signals. | One visit |
| Number of Subjects in Which Acoustic Respiratory Rate (RRa) Signals is Collected | All subjects enrolled into the study will receive the RAM sensor in order to records RRa signals. | One visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R Drover, M.D. | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Evaluation Group | All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring SedLine EEG RRa monitoring |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Evaluation Group | All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects in Which Electroencephalogram (EEG) Signals is Collected | Subjects enrolled into the study will have the SedLine sensor placed on the subject to collect EEG signals. | Posted | Count of Participants | Participants | One visit |
|
|
During the data collection period, which could of lasted up to 8 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Evaluation Group | All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vikram Ramakanth | Masimo Corporation | 9492977416 | vramakanth@masimo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2017 | Jan 6, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Number of Subjects in Which Acoustic Respiratory Rate (RRa) Signals is Collected | All subjects enrolled into the study will receive the RAM sensor in order to records RRa signals. | Posted | Count of Participants | Participants | One visit |
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| 0 |
| 51 |
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| 51 |
| 0 |
| 51 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |