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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cirrhosis | Drug: Zolpidem Drug: placebo | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: zolpidem
Tablet zolpidem 5mg once daily will be given for 4 weeks
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Drug: Zolpidem |
Placebo Comparator: Placebo
One tablet of placebo will be given for 4 weeks
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Drug: placebo |
- Improvement in quality of sleep in CHILD A/B cirrhosis patients after 4 weeks as measured by total sleep time [ Time Frame: 4 weeks ]
- Precipitation of Hepatic encephalopathy with Zolpidem [ Time Frame: 4 weeks ]
- Increase in daytime sleepiness with zolpidem as measured by ESS [ Time Frame: 4 weeks ]
- Improvement in sleep efficiency after treatment [ Time Frame: 4 weeks ]
- Reduction in periodic limb movements after treatment [ Time Frame: 4 weeks ]

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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 |
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

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
India | |
Institute of Liver and Biliary Sciences | |
New Delhi, Delhi, India, 110070 |
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 |
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 |