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NCT03091738 · ClinicalTrials.gov registry record · Phase 4
Ramelteon for Treatment of Insomnia in Cirrhosis
A Phase 4 study of Cirrhosis, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03091738: Completed Phase 4 study of Cirrhosis, sponsored by Virginia Commonwealth University.
NCT03091738 is a Phase 4 study of Cirrhosis that has completed, run by Virginia Commonwealth University. The registered enrollment target is 10 participants, below the 90,409-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03091738, a Phase 4 study of Cirrhosis, has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Pittsburgh Sleep Quality Index (PSQI) is a 19 item survey measuring 7 components of sleep. Component scores are summed to yield a global PSQI score. Scores range from 0 to 21 with higher scores indicate worse sleep quality.
Conditions Studied
Interventions
- DRUG Ramelteon Pill
Study Locations (1)
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-02-01 |
| Est. Completion | 2018-10-01 |
| Phase | Phase 4 |
What the finished NCT03091738 record still lists
NCT03091738 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 90,409-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Cirrhosis appearing as the primary indexed condition, and to 1 intervention - of which Ramelteon Pill is the first listed.
NCT03091738 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT03091738 about?
NCT03091738 is a clinical study titled "Ramelteon for Treatment of Insomnia in Cirrhosis". 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 di...
What is the current status of trial NCT03091738?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2017-02-01. Estimated completion is 2018-10-01.
What conditions does trial NCT03091738 study?
This clinical trial studies the following conditions: Cirrhosis.
What interventions are being tested in trial NCT03091738?
The interventions under investigation include: Ramelteon Pill (DRUG).
Who is sponsoring clinical trial NCT03091738?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03091738 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03091738's enrollment target sits among peer trials
10 52nd of 53 higher than 1 of 53 other Cirrhosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cirrhosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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