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

Delirium in Old Age Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03165695
• Other study ID #: 2017P000656
• Status: Withdrawn
• Phase: Phase 4
• Start date: December 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Delirium in Old Age

Intervention

Drug:
• Ramelteon
Ramelteon 8 mg tablet orally at 21:00 for 7 days or until discharge whichever comes first
• Placebo
Placebo, 1 tablet orally at 21:00 or until discharge whichever comes first

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of delirium	Incidence of delirium measured by DRS-98R	7 days or less depending on the length of hospital stay
Secondary	Severity of delirium	Decreased mean DRS-98R score	7 days or less depending on the length of hospital stay
Secondary	Sleep improvement	Improvement in sleep metrics: increased duration of sleep as measured by Actigraphy	7 days or less depending on the length of hospital stay