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

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ClinicalTrials.gov Identifier: NCT02484963
Recruitment Status : Completed
First Posted : June 30, 2015
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : January 15, 2017
Actual Study Completion Date : January 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 Measures :
  1. Precipitation of Hepatic encephalopathy with Zolpidem [ Time Frame: 4 weeks ]
  2. Increase in daytime sleepiness with zolpidem as measured by ESS [ Time Frame: 4 weeks ]
  3. Improvement in sleep efficiency after treatment [ Time Frame: 4 weeks ]
  4. Reduction in periodic limb movements after treatment [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484963


Locations
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India
Institute of Liver and Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
More Information
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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT02484963    
Other Study ID Numbers: ILBS-Insomnia-001
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: June 2016
Additional relevant MeSH terms:
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Zolpidem
Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
 Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action