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

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.

Study Overview

• Status: Completed
• Conditions: Cirrhosis
• Intervention / Treatment: Drug: placebo; Drug: Zolpidem

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2015
• Primary Completion (Actual): January 15, 2017
• Study Completion (Actual): January 15, 2017

Study Registration Dates

• First Submitted: May 22, 2015
• First Submitted That Met QC Criteria: June 29, 2015
• First Posted (Estimate): June 30, 2015

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 14, 2018
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Parasomnias; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Hypnotics and Sedatives; GABA Agents; Sleep Aids, Pharmaceutical; GABA-A Receptor Agonists; GABA Agonists; Zolpidem
• Other Study ID Numbers: ILBS-Insomnia-001