The Study of Spectrum of Sleep Disorders in Cirrhotic Patients and the Efficacy of Zolpidem in Cirrhotic Patients With Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Improvement in quality of sleep in CHILD A/B cirrhosis patients after 4 weeks as measured by total sleep time
研究概览
简要总结
All Cirrhosis liver patients (Child A/B/C) presenting to Institute of Liver and Biliary Sciences will be screened for sleep disturbance and excessive daytime sleepiness with Epworth sleep score/ Pittsburgh sleep quality index. 52 patients of clinical/ radiological/ biopsy proven cirrhosis (Child A/B) will be enrolled after ruling out possibility of psychiatric illnesses like depression and anxiety with the help of PHQ-9 / GAD-7 questionnares. Patients who are suffering with sleep disturbance as evaluated with Pittsburgh sleep quality index will undergo polysomnography and will be randomised to two groups after fulfilling all inclusion criterias. Patients in group (Group 1) will receive zolpidem 5mg at bed time daily and patients in control group will receive placebo at bed time daily. The treatment will be continued for 4 weeks. After 4 weeks enrolled patients will be reassessed with PSQI and polysomnography. All patients will be advised regarding sleep hygiene.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years
- •Clinical, Biochemical, Radiological ,Histological evidence of cirrhosis of all etiology
- •Child A and B cirrhosis (for intervention part)
- •Cirrhosis patients giving h/o persistent sleep disturbances (PSQI≥5)
- •Child A, B and C cirrhosis (for observational part)
排除标准
- •Active alcohol intake or intake within 1 month of enrollment
- •Active substance abuse or intake within 1 month of enrollment
- •Known psychiatric and neurological disorders
- •Patient using antidepressant, anticonvulsants, other hypnotics
- •Pregnancy or lactation
- •Overt hepatic encephalopathy (grade 2,3,4)
- •Child C cirrhosis (for intervention part)
- •Acute decompensated state of CLD (Chronic Liver Disease) - GastroIntestinal bleed, increased jaundice, HE (Hepatic Encepahlopahty) , SBP (Spontaneous Bacterial Peritonitis).
- •HCC (HepatoCellular Carcinoma) with portal vein thrombosis
- •Acute febrile illness/ acute infection
- •Post TIPS (Transjugular Intrahepatic Portosystemic shunt)patient
研究组 & 干预措施
zolpidem
Tablet zolpidem 5mg once daily will be given for 4 weeks
干预措施: Zolpidem (Drug)
Placebo
One tablet of placebo will be given for 4 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Improvement in quality of sleep in CHILD A/B cirrhosis patients after 4 weeks as measured by total sleep time
时间窗: 4 weeks
次要结局
- Increase in daytime sleepiness with zolpidem as measured by ESS(4 weeks)
- Precipitation of Hepatic encephalopathy with Zolpidem(4 weeks)
- Improvement in sleep efficiency after treatment(4 weeks)
- Reduction in periodic limb movements after treatment(4 weeks)