Delirium, Sleep Deprivation
Conditions
Brief summary
Sleep deprivation is known to affect brain function but is often ignored in the sickest patients including those in the intensive care unit after major surgery. In these patients, the levels of melatonin can also be altered. Melatonin is a hormone secreted in the brain that maintains the body's sleep-wake, or circadian, cycle. The investigators want to test whether improving sleep quality affects the risk of developing confusion (delirium) in patients having clot removed from their lung (open heart surgery). In order to improve sleep quality, the investigators will conduct a study of Ramelteon, a medication that mimics the activity of melatonin and measure its effects on levels of melatonin and monitor sleep.
Interventions
DRUGRamelteon
DRUGPlacebo
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) who are admitted to UCSD for a planned PTE surgery. * Age \> 18 years
Exclusion criteria
* Pregnancy * Cirrhosis of any etiology * Current use of any atypical antipsychotic including Fluvoxamine (contra-indicated with Ramelteon) * Any contraindication to EEG/Sleep recording * Non-English speaking (who are unable to complete delirium questionnaires)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Delirium | Twice daily for up to 10 days | Measured twice daily during the ICU stay using the Confusions Assessment Method instrument. |
| Total Duration of Sleep | Daily for up to 10 days | Participants wore an actigraphy device on their wrist for the duration of their ICU stay. This device continuously measures activity, and thus estimates sleep time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | Duration of hospital admission | — |
| Length of ICU Stay | Duration of hospital admission | — |
| Number of Participants With Delirium | Twice daily for up to 10 days | Measured twice daily over the course of the ICU stay using the Confusion Assessment Method instrument |
| Measures of the Sound Levels in the Patient's Room | 3 days | Sound meter was placed at bedside in each patient room. This meter measured and recorded the sound level in decibels every two seconds. |
| Measures of Light Quality in the Patient's Room | 3 days | Light meter placed at bedside in patient room; this meter measured and recorded the light level in lux for ever minutes. |
| Average Daily Critical Care Pain Observation Tool (CPOT) | 10 days | average daily pain level using the CPOT Participants can score from 0 to 6 on the CPOT scale, with 0 being no pain (calm, comfortable), and 6 representing significant pain/agitation. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Patients will receive a Placebo tablet every evening.
Placebo | 58 |
| Ramelteon Patients will receive Ramelteon 8mg every evening.
Ramelteon | 59 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Ramelteon | Total | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 39 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 78 Participants | 39 Participants |
| Age, Continuous | 58.1 years STANDARD_DEVIATION 14.1 | 57.1 years STANDARD_DEVIATION 14.9 | 56.1 years STANDARD_DEVIATION 15.8 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 59 participants | 117 participants | 58 participants |
| Sex: Female, Male Female | 30 Participants | 59 Participants | 29 Participants |
| Sex: Female, Male Male | 29 Participants | 58 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 61 | 3 / 59 |
| other Total, other adverse events | 0 / 61 | 0 / 59 |
| serious Total, serious adverse events | 0 / 61 | 0 / 59 |
Outcome results
Primary
Duration of Delirium
Measured twice daily during the ICU stay using the Confusions Assessment Method instrument.
Time frame: Twice daily for up to 10 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Duration of Delirium | 16 hours |
| Ramelteon | Duration of Delirium | 24 hours |
Primary
Total Duration of Sleep
Participants wore an actigraphy device on their wrist for the duration of their ICU stay. This device continuously measures activity, and thus estimates sleep time.
Time frame: Daily for up to 10 days
Population: Due to funding \& logistical constraints, only a subset of subjects would've been able to do the electroencephalography (EEG) monitoring used for sleep assessment. Thus, Total Duration of Sleep was not measured and we focused on our a priori secondary outcome of incident delirium, a change made before the start of data collection or analysis.
Secondary
Average Daily Critical Care Pain Observation Tool (CPOT)
average daily pain level using the CPOT Participants can score from 0 to 6 on the CPOT scale, with 0 being no pain (calm, comfortable), and 6 representing significant pain/agitation.
Time frame: 10 days
Secondary
Length of Hospital Stay
Time frame: Duration of hospital admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Length of Hospital Stay | 12 days |
| Ramelteon | Length of Hospital Stay | 12 days |
Secondary
Length of ICU Stay
Time frame: Duration of hospital admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Length of ICU Stay | 4 days |
| Ramelteon | Length of ICU Stay | 4 days |
Secondary
Measures of Light Quality in the Patient's Room
Light meter placed at bedside in patient room; this meter measured and recorded the light level in lux for ever minutes.
Time frame: 3 days
Secondary
Measures of the Sound Levels in the Patient's Room
Sound meter was placed at bedside in each patient room. This meter measured and recorded the sound level in decibels every two seconds.
Time frame: 3 days
Secondary
Number of Participants With Delirium
Measured twice daily over the course of the ICU stay using the Confusion Assessment Method instrument
Time frame: Twice daily for up to 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Delirium | 22 Participants |
| Ramelteon | Number of Participants With Delirium | 19 Participants |