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Completed

NCT Number: NCT02484963

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

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.

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Key information

Conditions

Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zolpidem

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 30, 2015
Registry last updated
May 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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