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Ramelteon for Treatment of Insomnia in Cirrhosis
Phase 4 trial testing Ramelteon Pill in Cirrhosis in 10 participants. Completed in 1 October 2018.
| Lead sponsor | Virginia Commonwealth University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 1 February 2017 |
| Primary completion | 1 October 2018 |
| Estimated completion | 1 October 2018 |
| Sites | 1 location across United States |
Virginia Commonwealth University
Adults 21 to 65, any sex, with Cirrhosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Ramelteon Pill | 4.63 | ± 2.97 |
| Group | Value | 95% CI |
|---|---|---|
| Ramelteon Pill | 11.75 | ± 4.68 |
Epworth Sleepiness Scale asks participants to rate (on a scale of 0 to 3) their likelihood of falling asleep during 8 daily activities. Scores range from 0 to 24 with lower scores indicating less sleepiness.
| Group | Value | 95% CI |
|---|---|---|
| Ramelteon Pill | 4.68 | ± 2.63 |
| Group | Value | 95% CI |
|---|---|---|
| Ramelteon Pill | 5.8 | ± 3.39 |
Sickness Impact Profile is a 68 question assessment. Items are scored 0 (no) or 1 (yes). Scores range from 0 to 68 with higher numbers indicating worse quality of life.
| Group | Value | 95% CI |
|---|---|---|
| Ramelteon Pill | 4.9 | ± 6.85 |
| Group | Value | 95% CI |
|---|---|---|
| Ramelteon Pill | 3.96 | ± 7.03 |
Time frame: 14 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Ramelteon Pill |
|---|---|---|
| Paradoxical reaction | Product Issues | — |
Data from ClinicalTrials.gov NCT03091738 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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