Trial Outcomes & Findings for Suvorexant and Sleep/Delirium in ICU Patients (NCT NCT04092894)
NCT ID: NCT04092894
Last Updated: 2025-10-27
Results Overview
Nighttime wakefulness after persistent sleep onset (WASO) will be measured using a SedLine® Brain Function Monitor. WASO will be defined as the duration of wakefulness after the onset of persistent sleep in the observation period between 11:00pm (Lights-Off) to 6:00am (Lights-On) in minutes. Onset of persistent sleep will be defined as the first epoch of 10 consecutive minutes of sleep (REM or non-REM Stages 1, 2, 3 or 4) after Lights-Off. Wakefulness will be defined as any epoch of Stage 0. Sleep staging will be performed according to Rechtschaffen \& Kales criteria and in accordance with AASM guidelines. The SedLine® monitor uses a symmetrical bilateral array of sensors that provides four-channel data.
COMPLETED
PHASE4
100 participants
First night after extubation between 11:00pm and 6:00am
2025-10-27
Participant Flow
Participant milestones
| Measure |
Suvorexant
Suvorexant 20 mg will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
Placebo
Placebo will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
51
|
|
Overall Study
Received study drug
|
47
|
47
|
|
Overall Study
COMPLETED
|
37
|
41
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
Reasons for withdrawal
| Measure |
Suvorexant
Suvorexant 20 mg will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
Placebo
Placebo will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Discontinued EEG after randomization
|
10
|
6
|
Baseline Characteristics
Suvorexant and Sleep/Delirium in ICU Patients
Baseline characteristics by cohort
| Measure |
Suvorexant
n=49 Participants
Suvorexant 20 mg will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
Placebo
n=51 Participants
Placebo will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
70 years
n=7 Participants
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First night after extubation between 11:00pm and 6:00amNighttime wakefulness after persistent sleep onset (WASO) will be measured using a SedLine® Brain Function Monitor. WASO will be defined as the duration of wakefulness after the onset of persistent sleep in the observation period between 11:00pm (Lights-Off) to 6:00am (Lights-On) in minutes. Onset of persistent sleep will be defined as the first epoch of 10 consecutive minutes of sleep (REM or non-REM Stages 1, 2, 3 or 4) after Lights-Off. Wakefulness will be defined as any epoch of Stage 0. Sleep staging will be performed according to Rechtschaffen \& Kales criteria and in accordance with AASM guidelines. The SedLine® monitor uses a symmetrical bilateral array of sensors that provides four-channel data.
Outcome measures
| Measure |
Suvorexant
n=37 Participants
Suvorexant 20 mg will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
Placebo
n=41 Participants
Placebo will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
|---|---|---|
|
Nighttime Wakefulness After Persistent Sleep Onset (WASO)
|
200.7 minutes
Interval 112.1 to 328.4
|
184.2 minutes
Interval 80.4 to 304.2
|
SECONDARY outcome
Timeframe: First night after extubation between 11:00pm and 6:00amTotal sleep time will be measured by electroencephalogram (EEG) using a Next Generation SedLine® Brain Function Monitor during the night of the sleep trial in analogy to the primary outcome.
Outcome measures
| Measure |
Suvorexant
n=37 Participants
Suvorexant 20 mg will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
Placebo
n=41 Participants
Placebo will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
|---|---|---|
|
Total Sleep Time (TST)
|
224 minuts
Interval 112.0 to 379.0
|
253 minuts
Interval 68.0 to 420.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: First night after extubation between 11:00pm and 6:00amSleep onset latency will be measured by electroencephalogram (EEG) using a Next Generation SedLine® Brain Function Monitor during the night of the sleep trial in analogy to the primary outcome.
Outcome measures
| Measure |
Suvorexant
n=37 Participants
Suvorexant 20 mg will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
Placebo
n=41 Participants
Placebo will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
|---|---|---|
|
Time to Sleep Onset (TSO)
|
30.5 miniutes
Interval 16.6 to 64.1
|
16.6 miniutes
Interval 6.8 to 34.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 hours after initiation of sleep trialContinuous EEG-monitoring throughout the day following the sleep trial will be performed until no more than 24 hours after initiation of the sleep trial, or until the patient is discharged from the ICU, whichever occurs first. Duration of sleep during the day will be assessed.
Outcome measures
| Measure |
Suvorexant
n=37 Participants
Suvorexant 20 mg will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
Placebo
n=41 Participants
Placebo will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
|---|---|---|
|
Duration of Sleep During the Day
|
553 minutes
Interval 507.0 to 684.0
|
565.5 minutes
Interval 463.0 to 657.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Every morning from preoperative day 3 up to postoperative day 7Subjective sleep quality will be assessed by applying the Richards-Campbell Sleep Questionnaire (RCSQ). The RCSQ is a validated survey instrument for assessing sleep quality in critically ill patients based on a five-item, visual analogue scale (each from 0 \[worst value\] to 100 \[best value\]). The scale evaluates perceptions of depth of sleep, sleep onset latency, number of awakenings, time spent awake, and overall sleep quality.
Outcome measures
| Measure |
Suvorexant
n=37 Participants
Suvorexant 20 mg will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
Placebo
n=41 Participants
Placebo will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
|---|---|---|
|
Subjective Sleep Quality: Richards-Campbell Sleep Questionnaire (RCSQ)
|
35.47 points
Interval 24.31 to 46.53
|
34.42 points
Interval 23.45 to 45.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Every day from postoperative day 1 up to day of hospital discharge, an expected average of 21 daysIncidence of postoperative delirium will be measured daily by the Confusion Assessment Method (CAM) and CAM-ICU. The CAM is a standardized screening tool used for identification of delirium symptoms through a diagnostic algorithm based on 4 cardinal features of delirium, namely acute onset and fluctuating course, inattention, disorganized thinking, and altered level of consciousness. The CAM-ICU, which is routinely performed in the ICU, includes both brief cognitive testing and the CAM algorithm to screen for delirium. For CAM-positive patients, the Delirium Symptom Interview, a standard cognitive assessment consisting of tests of attention, orientation, and memory will be performed by a research team members trained in the survey administration methodology and blinded to treatment assignment to verify the CAM screening results.
Outcome measures
| Measure |
Suvorexant
n=49 Participants
Suvorexant 20 mg will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
Placebo
n=51 Participants
Placebo will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
|---|---|---|
|
Postoperative Delirium
|
10 Participants
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Every day from postoperative day 1 up to day of hospital discharge, an expected average of 21 daysIncidence of postoperative delirium will be measured daily by the Confusion Assessment Method (CAM) and CAM-ICU. The CAM is a standardized screening tool used for identification of delirium symptoms through a diagnostic algorithm based on 4 cardinal features of delirium, namely acute onset and fluctuating course, inattention, disorganized thinking, and altered level of consciousness. The CAM-ICU, which is routinely performed in the ICU, includes both brief cognitive testing and the CAM algorithm to screen for delirium. For CAM-positive patients, the Delirium Symptom Interview, a standard cognitive assessment consisting of tests of attention, orientation, and memory will be performed by a research team members trained in the survey administration methodology and blinded to treatment assignment to verify the CAM screening results.
Outcome measures
| Measure |
Suvorexant
n=49 Participants
Suvorexant 20 mg will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
Placebo
n=51 Participants
Placebo will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
|---|---|---|
|
Delirium-free Days
|
7 days
Interval 6.0 to 10.0
|
7 days
Interval 6.0 to 11.0
|
Adverse Events
Suvorexant
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Suvorexant
n=49 participants at risk
Suvorexant 20 mg will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
Placebo
n=51 participants at risk
Placebo will be administered p.o. once a day between 9:00pm and 10:00pm for 7 days starting the night after extubation in the ICU.
|
|---|---|---|
|
Nervous system disorders
Somnolence
|
2.0%
1/49 • from enrollment until discharge
|
2.0%
1/51 • from enrollment until discharge
|
|
General disorders
Fatigue
|
2.0%
1/49 • from enrollment until discharge
|
0.00%
0/51 • from enrollment until discharge
|
|
Nervous system disorders
Abnormal thought/hallucination
|
4.1%
2/49 • from enrollment until discharge
|
0.00%
0/51 • from enrollment until discharge
|
Additional Information
Balachundhar Subramaniam
Beth Israel Deaconess Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place