Cirrhosis
Conditions
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.
Interventions
DRUGZolpidem
DRUGplacebo
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| 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 |
Countries
India
Outcome results
None listed