The Study of Spectrum of Sleep Disorders in Cirrhotic Patients and the Efficacy of Zolpidem in Cirrhotic Patients With Insomnia

Study Overview
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Brief Summary
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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.

Official Title
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The Study of Spectrum of Sleep Disorders in Cirrhotic Patients and the Efficacy of Zolpidem in Cirrhotic Patients With Insomnia

Conditions
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Cirrhosis

Intervention / Treatment
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* Drug: Zolpidem
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: zolpidem<br>Tablet zolpidem 5mg once daily will be given for 4 weeks | Drug: Zolpidem<br> <br> |
| Placebo Comparator: Placebo<br>One tablet of placebo will be given for 4 weeks | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in quality of sleep in CHILD A/B cirrhosis patients after 4 weeks as measured by total sleep time |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precipitation of Hepatic encephalopathy with Zolpidem |  | 4 weeks | 
| Increase in daytime sleepiness with zolpidem as measured by ESS |  | 4 weeks | 
| Improvement in sleep efficiency after treatment |  | 4 weeks | 
| Reduction in periodic limb movements after treatment |  | 4 weeks |