Trial Outcomes & Findings for Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine (NCT NCT04206059)
NCT ID: NCT04206059
Last Updated: 2026-05-01
Results Overview
EEG slow waves activity (power) relative to the timing of the stimulation. Values are log-transformed All participants serve in the same arm but experience both sham and in-phase blocks.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Sham stimulation and in-phase stimulation blocks during the intervention
Results posted on
2026-05-01
Participant Flow
2 participants were withdrawn after consent.
Participant milestones
| Measure |
CLASS-D Cohort
Dexmedetomidine: All participants will receive dexmedetomidine with sedation titrated stepwise to 2, 3 or 4 ng/ml.
Breathe-Squeeze Task: All participants will be asked to perform the breathe-squeeze task throughout the experiment. This will allow us to determine loss and return of responsiveness.
Subjects will receive multiple 5-minute blocks of acoustic stimulation during two states: 1. while performing the task; and 2. after becoming unresponsive to the task.
Quantitative Sensory Testing (QST): Quantitative sensory testing (QST) using increasing ramp thermal stimulation (32-52 ºC) will be delivered to compare arousal thresholds between conditions.
While performing task and after being unresponsive to the task: acoustic stimulation (65db) with up-slope of EEG with QST: 65 db acoustic stimulation synchronized with the up-slope of EEG slow waves (in-phase)
While performing task and after being unresponsive to the task: acoustic stimulation (65db) with down-slope of EEG with QST: 65 dB acoustic stimulation synchronized with the down-slope of the EEG slow waves (anti-phase)
While performing task and after being unresponsive to the task: sham stimulation (0 db stimulation) with QST MRI: A non-contrast brain MRI will be acquired for localizing EEG slow waves
Home sleep study: All subjects will prove unattended home sleep studies to be conducted on the night preceding and following the sedation to assess slow wave homeostasis changes.
|
|---|---|
|
Pre-sedation Sleep
STARTED
|
16
|
|
Pre-sedation Sleep
COMPLETED
|
16
|
|
Pre-sedation Sleep
NOT COMPLETED
|
0
|
|
Sedation
STARTED
|
16
|
|
Sedation
Acoustic Stimulation (65db) With Up-slope of EEG With QST
|
15
|
|
Sedation
Acoustic Stimulation (65db) With Down-slope of EEG With QST
|
15
|
|
Sedation
Sham Stimulation (0 db Stimulation) With QST
|
15
|
|
Sedation
COMPLETED
|
15
|
|
Sedation
NOT COMPLETED
|
1
|
|
Post-sedation Sleep
STARTED
|
15
|
|
Post-sedation Sleep
COMPLETED
|
15
|
|
Post-sedation Sleep
NOT COMPLETED
|
0
|
|
HD-EEG
STARTED
|
15
|
|
HD-EEG
COMPLETED
|
14
|
|
HD-EEG
NOT COMPLETED
|
1
|
|
MRI
STARTED
|
14
|
|
MRI
COMPLETED
|
0
|
|
MRI
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
CLASS-D Cohort
Dexmedetomidine: All participants will receive dexmedetomidine with sedation titrated stepwise to 2, 3 or 4 ng/ml.
Breathe-Squeeze Task: All participants will be asked to perform the breathe-squeeze task throughout the experiment. This will allow us to determine loss and return of responsiveness.
Subjects will receive multiple 5-minute blocks of acoustic stimulation during two states: 1. while performing the task; and 2. after becoming unresponsive to the task.
Quantitative Sensory Testing (QST): Quantitative sensory testing (QST) using increasing ramp thermal stimulation (32-52 ºC) will be delivered to compare arousal thresholds between conditions.
While performing task and after being unresponsive to the task: acoustic stimulation (65db) with up-slope of EEG with QST: 65 db acoustic stimulation synchronized with the up-slope of EEG slow waves (in-phase)
While performing task and after being unresponsive to the task: acoustic stimulation (65db) with down-slope of EEG with QST: 65 dB acoustic stimulation synchronized with the down-slope of the EEG slow waves (anti-phase)
While performing task and after being unresponsive to the task: sham stimulation (0 db stimulation) with QST MRI: A non-contrast brain MRI will be acquired for localizing EEG slow waves
Home sleep study: All subjects will prove unattended home sleep studies to be conducted on the night preceding and following the sedation to assess slow wave homeostasis changes.
|
|---|---|
|
Sedation
Withdrawal by Subject
|
1
|
|
HD-EEG
Withdrawal by Subject
|
1
|
|
MRI
Did not perform test
|
14
|
Baseline Characteristics
Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine
Baseline characteristics by cohort
| Measure |
CLASS-D Cohort
n=14 Participants
Dexmedetomidine: All participants will receive dexmedetomidine with sedation titrated stepwise to 2, 3 or 4 ng/ml.
Breathe-Squeeze Task: All participants will be asked to perform the breathe-squeeze task throughout the experiment. This will allow us to determine loss and return of responsiveness.
Subjects will receive multiple 5-minute blocks of acoustic stimulation during two states: 1. while performing the task; and 2. after becoming unresponsive to the task Quantitative Sensory Testing (QST): Quantitative sensory testing (QST) using increasing ramp thermal stimulation (32-52 ºC) will be delivered to compare arousal thresholds between conditions While performing task: acoustic stimulation (65db) with up-slope of EEG with QST: 65 db acoustic stimulation synchronized with the up-slope of EEG slow waves (in-phase) While performing task: acoustic stimulation (65db) with down-slope of EEG with QST: 65 dB acoustic stimulation synchronized with the down-slope of the EEG slow waves (anti-phase) While performing task: sham stimulation (0 db stimulation) with QST MRI: A non-contrast brain MRI will be acquired for localizing EEG slow waves Home sleep study: All subjects are to prove unattended home sleep studies to be conducted on the night preceding sedation and the night following sedation to assess changes in slow-wave homeostasis.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=14 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=14 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=14 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants
|
|
ASA Physical Status
ASA 1
|
14 Participants
n=14 Participants
|
|
ASA Physical Status
ASA 2
|
0 Participants
n=14 Participants
|
|
ASA Physical Status
ASA 3
|
0 Participants
n=14 Participants
|
|
ASA Physical Status
ASA 4
|
0 Participants
n=14 Participants
|
|
ASA Physical Status
ASA 5
|
0 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Sham stimulation and in-phase stimulation blocks during the interventionEEG slow waves activity (power) relative to the timing of the stimulation. Values are log-transformed All participants serve in the same arm but experience both sham and in-phase blocks.
Outcome measures
| Measure |
CLASS-D Cohort - Sham
n=14 Participants
Within-subject crossover cohort with intervention, acoustic stimulation anticipated in phase with the anticipated peak of EEG slow wave oscillation but no acoustic stimulation delivered.
|
CLASS-D Cohort In-phase
n=14 Participants
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated peak of EEG slow wave oscillation
|
|---|---|---|
|
Difference in EEG Slow Wave Activity From Sham to In-phase Stimulation
|
1.592 Log(μV squared)
Interval 1.093 to 2.017
|
1.694 Log(μV squared)
Interval 1.162 to 2.217
|
PRIMARY outcome
Timeframe: Anti-phase and in-phase blocks during the interventionEEG slow waves activity (power) relative to the timing of the stimulation. Values are log-transformed All participants serve in the same arm but experience both anti-phase and in-phase blocks.
Outcome measures
| Measure |
CLASS-D Cohort - Sham
n=14 Participants
Within-subject crossover cohort with intervention, acoustic stimulation anticipated in phase with the anticipated peak of EEG slow wave oscillation but no acoustic stimulation delivered.
|
CLASS-D Cohort In-phase
n=14 Participants
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated peak of EEG slow wave oscillation
|
|---|---|---|
|
Difference in EEG Slow Wave Activity From Anti-phase to In-phase Stimulation
|
1.511 log(μV squared)
Interval 1.014 to 1.885
|
1.694 log(μV squared)
Interval 1.162 to 2.217
|
PRIMARY outcome
Timeframe: anti-phase and in-phase blocks during the interventionDifference in EEG slow wave density from anti-phase to in-phase stimulation by looking at EEG slow waves duration relative to the timing of the stimulation All participants serve in the same arm but experience both anti-phase and in-phase blocks.
Outcome measures
| Measure |
CLASS-D Cohort - Sham
n=12 Participants
Within-subject crossover cohort with intervention, acoustic stimulation anticipated in phase with the anticipated peak of EEG slow wave oscillation but no acoustic stimulation delivered.
|
CLASS-D Cohort In-phase
n=12 Participants
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated peak of EEG slow wave oscillation
|
|---|---|---|
|
Difference in EEG Slow Wave Density From Anti-phase to In-phase Stimulation
|
6.9 waves/minute
Interval 0.0 to 24.0
|
6 waves/minute
Interval 0.0 to 18.9
|
PRIMARY outcome
Timeframe: Sham stimulation and in-phase stimulation blocks during the interventionDifference in EEG slow wave density from sham to in-phase stimulation by looking at EEG slow waves relative to the timing of the stimulation All participants serve in the same arm but experience both sham and in-phase blocks.
Outcome measures
| Measure |
CLASS-D Cohort - Sham
n=12 Participants
Within-subject crossover cohort with intervention, acoustic stimulation anticipated in phase with the anticipated peak of EEG slow wave oscillation but no acoustic stimulation delivered.
|
CLASS-D Cohort In-phase
n=12 Participants
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated peak of EEG slow wave oscillation
|
|---|---|---|
|
Difference in EEG Slow Wave Density From Sham to In-phase Stimulation
|
6 waves/minute
Interval 0.0 to 24.0
|
4.3 waves/minute
Interval 0.0 to 26.5
|
SECONDARY outcome
Timeframe: Anti-phase and in-phase blocks of the interventionDifference of reactivity to thermal stimulation from anti-phase to in-phase stimulation by measuring the threshold for responsiveness to thermal stimulation All participants serve in the same arm but experience both anti-phase and in-phase blocks.
Outcome measures
| Measure |
CLASS-D Cohort - Sham
n=14 Participants
Within-subject crossover cohort with intervention, acoustic stimulation anticipated in phase with the anticipated peak of EEG slow wave oscillation but no acoustic stimulation delivered.
|
CLASS-D Cohort In-phase
n=14 Participants
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated peak of EEG slow wave oscillation
|
|---|---|---|
|
Difference of Reactivity to Thermal Stimulation From Anti-phase to In-phase Stimulation
|
48.2 degrees celsius
Interval 37.4 to 51.6
|
50.5 degrees celsius
Interval 47.6 to 51.7
|
SECONDARY outcome
Timeframe: Sham and in-phase blocks during interventionDifference of reactivity to thermal stimulation from sham to in-phase stimulation by measuring the threshold for responsiveness to thermal stimulation All participants serve in the same arm but experience both sham and in-phase blocks.
Outcome measures
| Measure |
CLASS-D Cohort - Sham
n=14 Participants
Within-subject crossover cohort with intervention, acoustic stimulation anticipated in phase with the anticipated peak of EEG slow wave oscillation but no acoustic stimulation delivered.
|
CLASS-D Cohort In-phase
n=14 Participants
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated peak of EEG slow wave oscillation
|
|---|---|---|
|
Difference of Reactivity to Thermal Stimulation From Sham to In-phase Stimulation
|
48.5 degrees celsius
Interval 47.1 to 50.6
|
50.5 degrees celsius
Interval 47.6 to 51.7
|
SECONDARY outcome
Timeframe: on the nights before and the night of the interventionPopulation: Only one cohort as measures taken after all cross over conditions
Change in slow wave activity on the night of the intervention will be compared to that on the night prior to the study session. Calculated as power
Outcome measures
| Measure |
CLASS-D Cohort - Sham
n=13 Participants
Within-subject crossover cohort with intervention, acoustic stimulation anticipated in phase with the anticipated peak of EEG slow wave oscillation but no acoustic stimulation delivered.
|
CLASS-D Cohort In-phase
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated peak of EEG slow wave oscillation
|
|---|---|---|
|
Slow Wave Activity Calculated During N3 Sleep
|
8830 μV squared/Hz
Interval -60698.0 to 120256.0
|
—
|
Adverse Events
CLASS-D Cohort While Performing Task Without Sedation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CLASS-D Cohort While Performing Task With Sedation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CLASS-D Cohort Unresponsive During Sedation But Before CLAS
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
CLASS-D Cohort - In-phase After Becoming Unresponsive to Task
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CLASS-D Cohort - Anti-phase After Becoming Unresponsive to Task
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Comparator: CLASS-D Cohort - Sham After Becoming Unresponsive to Task
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CLASS-D Cohort Unresponsive During Sedation and After CLAS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CLASS-D Cohort Awake Performing Task While Recovering From Sedation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CLASS-D Cohort While Performing Task Without Sedation
n=16 participants at risk
Participants awake and performing task without sedation and before In-phase/anti-phase/sham CLAS administered. Task can only be performed when responsive.
|
CLASS-D Cohort While Performing Task With Sedation
n=16 participants at risk
Participants under sedation and performing task during dexmedetomidine sedation and before In-phase/anti-phase/sham CLAS administered. Task can only be performed when responsive.
|
CLASS-D Cohort Unresponsive During Sedation But Before CLAS
n=16 participants at risk
Participants no longer performing task during dexmedetomidine sedation and before In-phase/anti-phase/sham CLAS administered. Participant unresponsive
|
CLASS-D Cohort - In-phase After Becoming Unresponsive to Task
n=16 participants at risk
After participant unresponsive and no longer performing task since sedated with dexmedetomidine. Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated peak of EEG slow wave oscillation
|
CLASS-D Cohort - Anti-phase After Becoming Unresponsive to Task
n=16 participants at risk
After participant unresponsive and no longer performing task since sedated with dexmedetomidine. Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation
|
Sham Comparator: CLASS-D Cohort - Sham After Becoming Unresponsive to Task
n=16 participants at risk
After participant unresponsive and no longer performing task since sedated with dexmedetomidine. Within-subject crossover cohort with intervention, acoustic stimulation anticipated in phase with the anticipated peak of EEG slow wave oscillation but no acoustic stimulation delivered.
|
CLASS-D Cohort Unresponsive During Sedation and After CLAS
n=16 participants at risk
Participants sedated no during dexmedetomidine sedation and after In-phase/anti-phase/sham CLAS administered. Participant unresponsive and not performing task.
|
CLASS-D Cohort Awake Performing Task While Recovering From Sedation
n=16 participants at risk
Participants recovering from sedation and performing task during dexmedetomidine sedation and after In-phase/anti-phase/sham CLAS administered.
|
|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Restlessness
|
0.00%
0/16 • 1 week
Within subject trial. Participant performs task while responsive. Dexmedetomidine infusion initiated while participant performs task. After unresponsive and no longer performing task due to sedation with dexmedetomidine, cross-over with concomitant dexmedetomidine sedation: in-phase CLAS, anti-phase CLAS, and sham. Participant then recovers from the sedation while unresponsive. After awakening, participant performs task while recovering from dexmedetomidine.
|
0.00%
0/16 • 1 week
Within subject trial. Participant performs task while responsive. Dexmedetomidine infusion initiated while participant performs task. After unresponsive and no longer performing task due to sedation with dexmedetomidine, cross-over with concomitant dexmedetomidine sedation: in-phase CLAS, anti-phase CLAS, and sham. Participant then recovers from the sedation while unresponsive. After awakening, participant performs task while recovering from dexmedetomidine.
|
12.5%
2/16 • Number of events 2 • 1 week
Within subject trial. Participant performs task while responsive. Dexmedetomidine infusion initiated while participant performs task. After unresponsive and no longer performing task due to sedation with dexmedetomidine, cross-over with concomitant dexmedetomidine sedation: in-phase CLAS, anti-phase CLAS, and sham. Participant then recovers from the sedation while unresponsive. After awakening, participant performs task while recovering from dexmedetomidine.
|
0.00%
0/16 • 1 week
Within subject trial. Participant performs task while responsive. Dexmedetomidine infusion initiated while participant performs task. After unresponsive and no longer performing task due to sedation with dexmedetomidine, cross-over with concomitant dexmedetomidine sedation: in-phase CLAS, anti-phase CLAS, and sham. Participant then recovers from the sedation while unresponsive. After awakening, participant performs task while recovering from dexmedetomidine.
|
0.00%
0/16 • 1 week
Within subject trial. Participant performs task while responsive. Dexmedetomidine infusion initiated while participant performs task. After unresponsive and no longer performing task due to sedation with dexmedetomidine, cross-over with concomitant dexmedetomidine sedation: in-phase CLAS, anti-phase CLAS, and sham. Participant then recovers from the sedation while unresponsive. After awakening, participant performs task while recovering from dexmedetomidine.
|
0.00%
0/16 • 1 week
Within subject trial. Participant performs task while responsive. Dexmedetomidine infusion initiated while participant performs task. After unresponsive and no longer performing task due to sedation with dexmedetomidine, cross-over with concomitant dexmedetomidine sedation: in-phase CLAS, anti-phase CLAS, and sham. Participant then recovers from the sedation while unresponsive. After awakening, participant performs task while recovering from dexmedetomidine.
|
0.00%
0/16 • 1 week
Within subject trial. Participant performs task while responsive. Dexmedetomidine infusion initiated while participant performs task. After unresponsive and no longer performing task due to sedation with dexmedetomidine, cross-over with concomitant dexmedetomidine sedation: in-phase CLAS, anti-phase CLAS, and sham. Participant then recovers from the sedation while unresponsive. After awakening, participant performs task while recovering from dexmedetomidine.
|
0.00%
0/16 • 1 week
Within subject trial. Participant performs task while responsive. Dexmedetomidine infusion initiated while participant performs task. After unresponsive and no longer performing task due to sedation with dexmedetomidine, cross-over with concomitant dexmedetomidine sedation: in-phase CLAS, anti-phase CLAS, and sham. Participant then recovers from the sedation while unresponsive. After awakening, participant performs task while recovering from dexmedetomidine.
|
|
Cardiac disorders
bradycardia
|
0.00%
0/16 • 1 week
Within subject trial. Participant performs task while responsive. Dexmedetomidine infusion initiated while participant performs task. After unresponsive and no longer performing task due to sedation with dexmedetomidine, cross-over with concomitant dexmedetomidine sedation: in-phase CLAS, anti-phase CLAS, and sham. Participant then recovers from the sedation while unresponsive. After awakening, participant performs task while recovering from dexmedetomidine.
|
0.00%
0/16 • 1 week
Within subject trial. Participant performs task while responsive. Dexmedetomidine infusion initiated while participant performs task. After unresponsive and no longer performing task due to sedation with dexmedetomidine, cross-over with concomitant dexmedetomidine sedation: in-phase CLAS, anti-phase CLAS, and sham. Participant then recovers from the sedation while unresponsive. After awakening, participant performs task while recovering from dexmedetomidine.
|
12.5%
2/16 • Number of events 2 • 1 week
Within subject trial. Participant performs task while responsive. Dexmedetomidine infusion initiated while participant performs task. After unresponsive and no longer performing task due to sedation with dexmedetomidine, cross-over with concomitant dexmedetomidine sedation: in-phase CLAS, anti-phase CLAS, and sham. Participant then recovers from the sedation while unresponsive. After awakening, participant performs task while recovering from dexmedetomidine.
|
0.00%
0/16 • 1 week
Within subject trial. Participant performs task while responsive. Dexmedetomidine infusion initiated while participant performs task. After unresponsive and no longer performing task due to sedation with dexmedetomidine, cross-over with concomitant dexmedetomidine sedation: in-phase CLAS, anti-phase CLAS, and sham. Participant then recovers from the sedation while unresponsive. After awakening, participant performs task while recovering from dexmedetomidine.
|
0.00%
0/16 • 1 week
Within subject trial. Participant performs task while responsive. Dexmedetomidine infusion initiated while participant performs task. After unresponsive and no longer performing task due to sedation with dexmedetomidine, cross-over with concomitant dexmedetomidine sedation: in-phase CLAS, anti-phase CLAS, and sham. Participant then recovers from the sedation while unresponsive. After awakening, participant performs task while recovering from dexmedetomidine.
|
0.00%
0/16 • 1 week
Within subject trial. Participant performs task while responsive. Dexmedetomidine infusion initiated while participant performs task. After unresponsive and no longer performing task due to sedation with dexmedetomidine, cross-over with concomitant dexmedetomidine sedation: in-phase CLAS, anti-phase CLAS, and sham. Participant then recovers from the sedation while unresponsive. After awakening, participant performs task while recovering from dexmedetomidine.
|
0.00%
0/16 • 1 week
Within subject trial. Participant performs task while responsive. Dexmedetomidine infusion initiated while participant performs task. After unresponsive and no longer performing task due to sedation with dexmedetomidine, cross-over with concomitant dexmedetomidine sedation: in-phase CLAS, anti-phase CLAS, and sham. Participant then recovers from the sedation while unresponsive. After awakening, participant performs task while recovering from dexmedetomidine.
|
0.00%
0/16 • 1 week
Within subject trial. Participant performs task while responsive. Dexmedetomidine infusion initiated while participant performs task. After unresponsive and no longer performing task due to sedation with dexmedetomidine, cross-over with concomitant dexmedetomidine sedation: in-phase CLAS, anti-phase CLAS, and sham. Participant then recovers from the sedation while unresponsive. After awakening, participant performs task while recovering from dexmedetomidine.
|
Additional Information
Dr. Ben Palanca
Washington University School of Medicine
Phone: 314-273-9076
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place