The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery

Study Overview
=================
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.

Official Title
-----------------
The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery

Conditions
-----------------
Delirium, Sleep Deprivation

Intervention / Treatment
-----------------
* Drug: Ramelteon
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Patients will receive a Placebo tablet every evening. | Drug: Placebo<br> <br> |
| Active Comparator: Ramelteon<br>Patients will receive Ramelteon 8mg every evening. | Drug: Ramelteon<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Delirium | Measured twice daily during the ICU stay using the Confusions Assessment Method instrument. | Twice daily for up to 10 days | 
| 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. | Daily for up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Delirium | Measured twice daily over the course of the ICU stay using the Confusion Assessment Method instrument | Twice daily for up to 10 days | 
| 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. | 10 days | 
| Length of Hospital Stay |  | Duration of hospital admission | 
| Length of ICU Stay |  | Duration of hospital admission | 
| 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. | 3 days | 
| 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. | 3 days |