Clinical trial NCT02484963: The Study of Spectrum of Sleep Disorders in Cirrhotic Patients and the Efficacy of Zolpidem in Cirrhotic Patients With Insomnia
Official title: The Study of Spectrum of Sleep Disorders in Cirrhotic Patients and the Efficacy of Zolpidem in Cirrhotic Patients With Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Improvement in quality of sleep in CHILD A/B cirrhosis patients after 4 weeks as measured by total sleep time
timeFrame: 4 weeks
Secondary outcomes:
measure: Precipitation of Hepatic encephalopathy with Zolpidem
timeFrame: 4 weeks
measure: Increase in daytime sleepiness with zolpidem as measured by ESS
timeFrame: 4 weeks
measure: Improvement in sleep efficiency after treatment
timeFrame: 4 weeks
measure: Reduction in periodic limb movements after treatment
timeFrame: 4 weeks
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References: