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

NCT02484963 | Completed

• 1 other identifier: ILBS-Insomnia-001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Improvement in quality of sleep in CHILD A/B cirrhosis patients after 4 weeks as measured by total sleep time

  4 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

zolpidem

EXPERIMENTAL

Tablet zolpidem 5mg once daily will be given for 4 weeks

Drug: Zolpidem

Placebo

PLACEBO COMPARATOR

One tablet of placebo will be given for 4 weeks

Drug: placebo

Interventions

Zolpidem DRUG

zolpidem

placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Fibrosis

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: June 30, 2015
• Study Start: May 15, 2015
• Primary Completion: January 15, 2017
• Study Completion: January 15, 2017
• Last Updated: May 17, 2018

Record last verified: 2016-06

Locations

IN (1)