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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02484963
• Other study ID #: ILBS-Insomnia-001
• Status: Completed
• Phase: N/A
• Start date: May 15, 2015
• Est. completion date: January 15, 2017

Study information

• Verified date: June 2016
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 15, 2017
• Est. primary completion date: January 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Parasomnias
• Sleep Wake Disorders

Intervention

Drug:
• Zolpidem

• placebo

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in quality of sleep in CHILD A/B cirrhosis patients after 4 weeks as measured by total sleep time		4 weeks
Secondary	Precipitation of Hepatic encephalopathy with Zolpidem		4 weeks
Secondary	Increase in daytime sleepiness with zolpidem as measured by ESS		4 weeks
Secondary	Improvement in sleep efficiency after treatment		4 weeks
Secondary	Reduction in periodic limb movements after treatment		4 weeks