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Ramelteon vs Placebo for Prevention of Delirium and Improvement of Sleep in Hospitalized Older Adults

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03165695
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
30
Anticipated Duration (Days)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates whether Ramelteon can prevent delirium, decrease the severity of incident delirium and improve sleep wake cycle in hospitalized elderly surgical patients. Half of the patients will be assigned to Ramelteon, while other half will be assigned to placebo.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Delirium is a common clinical syndrome characterized by acute cognitive dysfunction with core features of inattention, disorganized thinking, perceptual disturbances and sleep-wake cycle disruption. It is typically multifactorial and can be triggered by acute infection, metabolic derangements, surgery, and certain medications. Older adults have a much higher incidence of delirium. Delirium increases in-hospital mortality, length of stay, rate of institutionalization and may cause or exacerbate cognitive impairment. The present pilot study investigates sleep loss as potentially important contributing factors in delirium and an opportunity for intervention. Sleep disruption is prevalent among hospitalized patients. Sufficient sleep is important for recovery from illness, management of pain, wound healing, and a variety of other biologic functions integral to recovery in addition to its putative role in delirium prevention. Melatonin plays an important role in circadian rhythms and sleep-wake cycle regulation. Melatonin secretion is altered in hospitalized older patients in comparison with community-living older individuals. Melatonin and the melatonin-receptor agonist Ramelteon have been studied and have shown promise in delirium prevention, in addition to promoting sleep. We propose to test the use of Ramelteon to decrease delirium and improve sleep/wake cycles in the elderly surgical patients.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Ramelteon vs Placebo for Prevention of Delirium and Improvement of Sleep in Hospitalized Older Adults
Anticipated Study Start Date :
Dec 1, 2019
Anticipated Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ramelteon Arm

Ramelteon tablet 8 mg orally at 21:00 for 7 days or until discharge whichever comes first.

Drug: Ramelteon
Ramelteon 8 mg tablet orally at 21:00 for 7 days or until discharge whichever comes first
Other Names:
  • Rozerem

    		•
    Placebo Comparator: Placebo Arm

    Sugar pill manufactured to mimic Ramelteon 8 mg tablet orally at 21:00 for 7 days or until discharge whichever comes first.

    Drug: Placebo
    Placebo, 1 tablet orally at 21:00 or until discharge whichever comes first

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of delirium [7 days or less depending on the length of hospital stay]

      Incidence of delirium measured by DRS-98R

    Secondary Outcome Measures

    1. Severity of delirium [7 days or less depending on the length of hospital stay]

      Decreased mean DRS-98R score

    2. Sleep improvement [7 days or less depending on the length of hospital stay]

      Improvement in sleep metrics: increased duration of sleep as measured by Actigraphy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 65 years of age or older.

    • Admitted to BWH vascular surgical service.

    • Able to provide informed consent or a surrogate is available to provide informed consent.

    • Absence of delirium at time of consent.

    Exclusion Criteria:

    • Expected stay or life expectancy less than 48 hours

    • Unable to take medications orally

    • Advanced liver disease (Child-Pugh class B or worse)

    • Active treatment with Fluvoxamine

    • Active treatment with antipsychotic medications, benzodiazepines or other hypnotic agents (i.e. Trazodone, Mirtazapine, Zolpidem, Zaleplon)

    • Known or suspected diagnosis of Lewy body dementia

    • Any dermatological condition that may be aggravated by using a wrist sensor.

    • Known pre-existing sleep disorder other than insomnia.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brigham and Women's Hospital Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Brigham and Women's Hospital

    Investigators

    • Principal Investigator: Elizabeth B Klerman, M.D.,PhD, Brigham and Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elizabeth B. Klerman, Associate Professor of Medicine, Harvard Medical School, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT03165695
    Other Study ID Numbers:
    • 2017P000656
    First Posted:
    May 24, 2017
    Last Update Posted:
    Jan 22, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Elizabeth B. Klerman, Associate Professor of Medicine, Harvard Medical School, Brigham and Women's Hospital
    Delirium
    Insomnia
    Ramelteon
    Additional relevant MeSH terms:
    Delirium

    Study Results

    No Results Posted as of Jan 22, 2020