Ramelteon vs Placebo for Prevention of Delirium and Improvement of Sleep in Hospitalized Older Adults
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 2/1/2019 |
| Start Date: | June 1, 2019 |
| End Date: | December 31, 2019 |
| Contact: | Elizabeth B Klerman, M.D.,PhD |
| Email: | ebklerman@research.bwh.harvard.edu |
| Phone: | 6173314580 |
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.
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.
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.
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.
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.
We found this trial at
1
site
75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-331-4580
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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