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

Primary Purpose

Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Zolpidem
placebo
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institute of Liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

zolpidem

Placebo

Arm Description

Tablet zolpidem 5mg once daily will be given for 4 weeks

One tablet of placebo will be given for 4 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Precipitation of Hepatic encephalopathy with Zolpidem
Increase in daytime sleepiness with zolpidem as measured by ESS
Improvement in sleep efficiency after treatment
Reduction in periodic limb movements after treatment

Full Information

First Posted
May 22, 2015
Last Updated
May 14, 2018
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT02484963
Brief Title
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

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
May 15, 2015 (Actual)
Primary Completion Date
January 15, 2017 (Actual)
Study Completion Date
January 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
zolpidem
Arm Type
Experimental
Arm Description
Tablet zolpidem 5mg once daily will be given for 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One tablet of placebo will be given for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Zolpidem
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Improvement in quality of sleep in CHILD A/B cirrhosis patients after 4 weeks as measured by total sleep time
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Precipitation of Hepatic encephalopathy with Zolpidem
Time Frame
4 weeks
Title
Increase in daytime sleepiness with zolpidem as measured by ESS
Time Frame
4 weeks
Title
Improvement in sleep efficiency after treatment
Time Frame
4 weeks
Title
Reduction in periodic limb movements after treatment
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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