Safety and Efficacy of Lemborexant for Patients With Cirrhosis and Sleep Problems: a Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Sleep quality
研究概览
简要总结
Sleep disturbance poses significant in patients with liver cirrhosis and is associated with impaired quality of life and worsening clinical status. Current pharmacological options remain limited and often have safety concerns due to altered hepatic metabolism. Lemborexant, a dual orexin receptor antagonist, promotes physiological sleep by inhibiting orexin-mediated wakefulness pathways. This study aims to evaluate the efficacy and safety of lemborexant for improving sleep in patients with liver cirrhosis.
详细描述
Patients with liver cirrhosis frequently experience sleep-wake disturbances such as insomnia, delayed sleep onset, or fragmented sleep. These disturbances may contribute to neurocognitive dysfunction and precipitate hepatic encephalopathy. However, conventional hypnotics such as benzodiazepines may worsen encephalopathy and are generally avoided.
Lemborexant selectively antagonizes orexin receptors OX1R and OX2R, modulating sleep without profound respiratory suppression or GABAergic effects. This randomized, three-armed, double-blind placebo-controlled trial aims to determine whether lemborexant improves sleep quality in patients with cirrhosis while maintaining acceptable neurocognitive and safety outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults aged 18 years or older;
- •willingness to participate in the clinical trial as evidenced by written informed consent; documented diagnosis of liver cirrhosis in the medical record, with disease severity assessed using the Child-Pugh score and supported by imaging findings consistent with cirrhosis on FibroScan or ultrasonography;
- •presence of sleep disturbance defined by a Pittsburgh Sleep Quality Index (PSQI) score greater than 5;
- •patients receiving inpatient or outpatient care at Cipto Mangunkusumo National General Hospital;
- •ability to take oral medication;
- •willingness of the patient or caregiver to maintain a sleep diary throughout the study period;
- •ability of the patient or caregiver to comply with the clinical trial protocol and complete scheduled serial assessments.
排除标准
- •advanced liver cirrhosis defined as Child-Pugh class C;
- •current use of medications with significant interactions affecting the metabolism of Lemborexant, including itraconazole, clarithromycin, fluconazole, verapamil, tramadol, rifampicin, carbamazepine, bosentan, efavirenz, etravirine, and modafinil;
- •ongoing alcohol consumption or intake of grapefruit juice during the study period;
- •pregnancy, breastfeeding, or plans to become pregnant during the study;
- •presence of significant comorbid conditions such as autoimmune disease,
- •stage V chronic kidney disease, HIV/AIDS, or known or suspected hypersensitivity to the investigational drug;
- •concurrent participation in another clinical trial at the time of screening.
研究组 & 干预措施
5 mg lemborexant
Lemborexant 5 mg orally once nightly before bedtime
干预措施: Lemborexant (Drug)
10 mg lemborexant
Lemborexant 10 mg orally once nightly before bedtime
干预措施: Lemborexant (Drug)
Placebo
Placebo orally once nightly before bedtime
干预措施: Placebo (Drug)
结局指标
主要结局
Sleep quality
时间窗: From enrollment to the end of treatment at 2 weeks
PSQI score
次要结局
- Hepatic Encephalopathy - Stroop Test(From enrollment to the end of treatment at 2 weeks)
- Liver function tests(From enrollment to the end of treatment at 2 weeks)
- Persistence of effects (sleep quality)(PSQI changes post-crossover at week 2 - week 4)
研究者
Rino Alvani Gani
Professor, Hepatologist, Internist
Indonesia University