Obstructive Sleep Apnea (OSA)
Conditions
Brief summary
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.
Interventions
DEVICESedLine EEG
DEVICERRa monitoring
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects in Which Electroencephalogram (EEG) Signals is Collected | One visit | Subjects enrolled into the study will have the SedLine sensor placed on the subject to collect EEG signals. |
| Number of Subjects in Which Acoustic Respiratory Rate (RRa) Signals is Collected | One visit | All subjects enrolled into the study will receive the RAM sensor in order to records RRa signals. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Evaluation Group All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring. | 47 |
| Total | 47 |
Baseline characteristics
| Characteristic | Evaluation Group |
|---|---|
| Age, Continuous | 52 years |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Region of Enrollment United States | 47 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
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.
Time frame: One visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Evaluation Group | Number of Subjects in Which Acoustic Respiratory Rate (RRa) Signals is Collected | 47 Participants |
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.
Time frame: One visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Evaluation Group | Number of Subjects in Which Electroencephalogram (EEG) Signals is Collected | 47 Participants |