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

Institute of Liver and Biliary Sciences, India

Status

Completed

Conditions

Cirrhosis

Treatments

Drug: Zolpidem

Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02484963

ILBS-Insomnia-001

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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