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

• Status: Completed
• Trial end date: 2017-01-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Zolpidem

Criteria

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