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

• Sponsor: Institute of Liver and Biliary Sciences, India (Other)
• Overall Status: Completed
• CT.gov ID: NCT02484963
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.1
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis	Drug: Zolpidem; Drug: placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Study of Spectrum of Sleep Disorders in Cirrhotic Patients and the Efficacy of Zolpidem in Cirrhotic Patients With Insomnia
• Actual Study Start Date: May 15, 2015
• Actual Primary Completion Date: Jan 15, 2017
• Actual Study Completion Date: Jan 15, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: zolpidem Tablet zolpidem 5mg once daily will be given for 4 weeks	Drug: Zolpidem
Placebo Comparator: Placebo One tablet of placebo will be given for 4 weeks	Drug: placebo

Outcome Measures

Primary Outcome Measures

1. Improvement in quality of sleep in CHILD A/B cirrhosis patients after 4 weeks as measured by total sleep time [4 weeks]

Secondary Outcome Measures

1. Precipitation of Hepatic encephalopathy with Zolpidem [4 weeks]

2. Increase in daytime sleepiness with zolpidem as measured by ESS [4 weeks]

3. Improvement in sleep efficiency after treatment [4 weeks]

4. Reduction in periodic limb movements after treatment [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver and Biliary Sciences	New Delhi	Delhi	India	110070

Sponsors and Collaborators

• Institute of Liver and Biliary Sciences, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institute of Liver and Biliary Sciences, India
• ClinicalTrials.gov Identifier: NCT02484963
• Other Study ID Numbers: ILBS-Insomnia-001
• First Posted: Jun 30, 2015
• Last Update Posted: May 17, 2018
• Last Verified: Jun 1, 2016

• Additional relevant MeSH terms: Sleep Wake Disorders; Parasomnias; Zolpidem

Study Results

No Results Posted as of May 17, 2018