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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

Tracking Information
First Submitted Date  ICMJE May 22, 2015
First Posted Date  ICMJE June 30, 2015
Last Update Posted Date May 17, 2018
Actual Study Start Date  ICMJE May 15, 2015
Actual Primary Completion Date January 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
Improvement in quality of sleep in CHILD A/B cirrhosis patients after 4 weeks as measured by total sleep time [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 29, 2015)
Composite outcome: Subjective and objective improvement in quantity and quality of sleep variables like latency to persistent sleep, sleep efficiency, wake time after sleep onset and number of awakenings. [ Time Frame: 4 weeks ]
Improvement in patient's sleepiness after treatment will be measured by
  1. Improvement in Epworth sleepiness scale score or to <10.
  2. Improvement in Pittsburgh Sleep Quality Index (PSQI) or to < 5.
  3. Improvement in Insomnia severity index score.
  4. Polysomnography Scale.
Change History Complete list of historical versions of study NCT02484963 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2015)
The prevalence of different sleep disorders in cirrhosis. [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Study of Spectrum of Sleep Disorders in Cirrhotic Patients and the Efficacy of Zolpidem in Cirrhotic Patients With Insomnia
Official Title  ICMJE The Study of Spectrum of Sleep Disorders in Cirrhotic Patients and the Efficacy of Zolpidem in Cirrhotic Patients With Insomnia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cirrhosis
Intervention  ICMJE
  • Drug: Zolpidem
  • Drug: placebo
Study Arms  ICMJE
  • Experimental: zolpidem
    Tablet zolpidem 5mg once daily will be given for 4 weeks
    Intervention: Drug: Zolpidem
  • Placebo Comparator: Placebo
    One tablet of placebo will be given for 4 weeks
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2017)
52
Original Estimated Enrollment  ICMJE
 (submitted: June 29, 2015)
50
Actual Study Completion Date  ICMJE January 15, 2017
Actual Primary Completion Date January 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02484963
Other Study ID Numbers  ICMJE ILBS-Insomnia-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institute of Liver and Biliary Sciences, India
Study Sponsor  ICMJE Institute of Liver and Biliary Sciences, India
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institute of Liver and Biliary Sciences, India
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP