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

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ClinicalTrials.gov Identifier: NCT02691013
Recruitment Status : Active, not recruiting
First Posted : February 24, 2016
Results First Posted : September 20, 2019
Last Update Posted : December 30, 2020
Sponsor:
Information provided by (Responsible Party):
Robert L. Owens, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Delirium Sleep Deprivation Drug: Ramelteon Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery
Actual Study Start Date : February 2016
Actual Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
Drug Information available for: Ramelteon

Arm Intervention/treatment
Placebo Comparator: Placebo
Patients will receive a Placebo tablet every evening.
Drug: Placebo
Active Comparator: Ramelteon
Patients will receive Ramelteon 8mg every evening.
Drug: Ramelteon



Primary Outcome Measures :
  1. Duration of Delirium [ Time Frame: Twice daily for up to 10 days ]
    Measured twice daily during the ICU stay using the Confusions Assessment Method instrument.

  2. Total Duration of Sleep [ Time Frame: 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 Outcome Measures :
  1. Number of Participants With Delirium [ Time Frame: Twice daily for up to 10 days ]
    Measured twice daily over the course of the ICU stay using the Confusion Assessment Method instrument

  2. Average Daily Critical Care Pain Observation Tool (CPOT) [ Time Frame: 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.

  3. Length of Hospital Stay [ Time Frame: Duration of hospital admission ]
  4. Length of ICU Stay [ Time Frame: Duration of hospital admission ]
  5. Measures of Light Quality in the Patient's Room [ Time Frame: 3 days ]
    Light meter placed at bedside in patient room; this meter measured and recorded the light level in lux for ever minutes.

  6. Measures of the Sound Levels in the Patient's Room [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691013


Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Robert Owens 8686577118
  Study Documents (Full-Text)

Documents provided by Robert L. Owens, University of California, San Diego:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert L. Owens, Associate Professor, Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02691013    
Other Study ID Numbers: 151294
First Posted: February 24, 2016    Key Record Dates
Results First Posted: September 20, 2019
Last Update Posted: December 30, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Delirium
Sleep Deprivation
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Dyssomnias
Sleep Wake Disorders