Ramelteon for Treatment of Insomnia in Cirrhosis

Completed · Phase 4

Conditions studied: Cirrhosis

In brief

To study the effect of ramelteon, a melatonin receptor agonist, on sleep quality, duration and cognitive function in cirrhotics with insomnia. Patients with cirrhosis have difficulties with their sleep quality, which adversely affects their health-related quality of life. It is assumed the sleep disturbances are related to hepatic encephalopathy (HE) in these patients. However, several recent reports have indicated that this is not a perfect concordance and that cognition is not related to sleep disturbance. The mechanism for this change is not clear, although there is evidence of melatonin-delayed phase in these patients as well as difficulties with the excretion pattern of cortisol. Ghrelin is an orexigenic hormone produced by the stomach which stimulates the appetite and also has a profound effect on sleep. Our group has demonstrated a substantial alteration in ghrelin secretion in cirrhosis that correlates with poor slow-wave sleep. In healthy individuals, ghrelin injection encourages slow-wave sleep while sleep deprivation increases ghrelin levels. The role of ghrelin in the sleep disturbances of cirrhosis has not been determined. Prior studies have also lacked the use of overnight polysomnography as a tool and have relied on either actigraphy or questionnaires. There is a need for detailed mechanistic and therapeutic approaches to analyzing sleep disturbances in cirrhosis. Also the therapy of sleep disturbance in cirrhosis is largely empirical. Prior studies have evaluated hydroxyzine which runs the risk of precipitating HE. Ramelteon is a melatonin analog that is FDA-approved for use in insomnia and will potentially be useful to restore the sleep-wake cycle in cirrhosis-associated sleep disturbance. The investigators aim to study the impact of the FDA-approved ramelteon on the sleep quality (using questionnaires and sleep diaries) on these patients with cirrhosis.

Key facts

Study ID

NCT03091738

Run by

Virginia Commonwealth University

People needed

10

Starts

2017-02-01

Expected to finish

2018-10-01

Last updated by the study team

2021-03-29

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Child class A cirrhosis proven by biopsy, radiology or endoscopic evidence of varices - Able to give informed consent

You may not qualify if…

• Patient unwilling to start therapy
• Allergic reactions to ramelteon in the past
• Obstructive sleep apnea
• Periodic limb movement disorder
• Moderate to severe depression
• Unable to give informed consent
• Night shift workers
• Inter-continental travel within the last 4 weeks
• Renal insufficiency on dialysis
• Current alcohol or illicit drug use
• Diabetes Mellitus using insulin therapy
• Use of chronic hypnotic medications more than once per week or more than 5-6 times per month

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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