Daridorexant for Sleep Disturbance in Adults With Liver Cirrhosis

Phase 4Not Yet RecruitingNCT07830303

Wang Fengmei180 enrolled

Overview

This study will evaluate the efficacy and safety of daridorexant, a dual orexin receptor antagonist, in adults with liver cirrhosis and sleep disturbance, including participants with or without covert hepatic encephalopathy. Sleep disturbance is common in people with liver cirrhosis and may affect quality of life and cognitive function. Participants will be randomly assigned to receive either daridorexant or a matching placebo for 30 days. Neither participants nor study investigators will know which treatment is assigned during the study, except when unblinding is medically necessary. Sleep and cognitive function will be assessed during the study using sleep monitoring, the Psychometric Hepatic Encephalopathy Score (PHES), and the Stroop EncephalApp, together with other clinical and laboratory assessments. The main purpose of the study is to determine whether daridorexant improves sleep efficiency compared with placebo after 30 days. The study will also evaluate changes in sleep quality, sleep structure, cognitive function, the occurrence or improvement of covert hepatic encephalopathy, and the safety of daridorexant. A total of 180 participants are planned to be enrolled at multiple participating hospitals and will be randomly assigned in a 1:1 ratio to daridorexant or placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

180

Conditions

Liver Cirrhosis Sleep Disturbance

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18-60 years. 2. Confirmed liver cirrhosis based on imaging, pathology, or clinical diagnosis. 3. Child-Pugh class A or B liver function; participants with hepatic encephalopathy must have covert hepatic encephalopathy (minimal hepatic encephalopathy \[MHE\]) or West-Haven grade I hepatic encephalopathy. 4. Insomnia supported by both subjective and objective evidence, including a Pittsburgh Sleep Quality Index (PSQI) total score \>5 and objective polysomnography (PSG) or actigraphy findings. 5. Provision of written informed consent. Exclusion Criteria: 1. Age \<18 years or \>60 years. 2. Child-Pugh class C liver function. 3. Overt hepatic encephalopathy of West-Haven grade II or higher. 4. Concomitant use of strong CYP3A4 inhibitors, such as itraconazole or ketoconazole, or strong CYP3A4 inducers, such as carbamazepine or rifampin. 5. Severe respiratory insufficiency or uncontrolled severe obstructive sleep apnea. 6. Pregnancy or breastfeeding. 7. Narcolepsy. 8. Known hypersensitivity to daridorexant or any of its excipients. 9. Concomitant use of central nervous system depressants, including alcohol, benzodiazepines, or opioids, that may increase sedation or somnolence. 10. Active severe psychiatric disorders, such as depression with suicidal ideation or a history of suicidal ideation, or a history of substance abuse. 11. Any contraindication to daridorexant.

Outcomes

Primary Outcomes

Percent Improvement From Baseline in Sleep Efficiency at Day 30

Sleep efficiency (SE) measured by overnight polysomnography (PSG). The primary endpoint is the percent improvement in sleep efficiency from baseline to Day 30.