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Trial record 33 of 390 for:    Recruiting, Not yet recruiting, Available Studies | Cirrhosis

Sleep Timing and Circadian Preferences in A Sample of Egyptian Patients With Hepatic Cirrhosis

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ClinicalTrials.gov Identifier: NCT02710227
Recruitment Status : Not yet recruiting
First Posted : March 16, 2016
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Brief Summary:
Individuals with hepatic cirrhosis (n=50) and healthy controls (n=30) were recruited. Sleep quality, sleep timing parameters and circadian preference were evaluated using the Pittsburgh Sleep Quality Index (PSQI), Sleep Timing Questionnaire (STQ) and The Composite Scale for Morningness (CSM) respectively

Condition or disease Intervention/treatment
Liver Cirrhosis Other: (PSQI), (STQ).

Detailed Description:

Cirrhosis of the liver is a chronic, diffuse, degenerative disease in which the parenchyma deteriorates, the lobules are infiltrated with fat and structurally altered, dense perilobular connective tissue forms and often areas of regeneration develop. These regeneration nodules have a reduced blood supply resulting in impaired liver function [1] and [2]. Factors that are taken into account to determine the severity of cirrhosis include serum albumin, prothrombin concentration, serum bilirubin, ascites and encephalopathy. A point system known as the Child's-pough-Turcotte score has been designed to determine the severity of cirrhosis. Depending on the total score, patients are classified as class A (early cirrhosis) through class C (advanced cirrhosis) [3].

A disturbance of sleep is recognized as one of the early signs of hepatic encephalopathy. Reversal of sleep rhythm, drowziness and lethargy are classic signs of this disease. Sleep disturbance and excessive daytime somnolence are common in patients with cirrhosis. It was estimated that up to 70% of individuals with cirrhosis (regardless of etiology) experience sleep disturbances [4]. Difficulty falling asleep and a shift in sleep schedule toward the latter part of the night, which might be result in daytime sleepiness, are commonly reported findings in patients with hepatic cirrhosis without encephalopathy [4].

Individuals with hepatic cirrhosis (n=50) and healthy controls (n=30) were recruited. Sleep quality, sleep timing parameters and circadian preference were evaluated using the Pittsburgh Sleep Quality Index (PSQI), Sleep Timing Questionnaire (STQ) and The Composite Scale for Morningness (CSM) respectively


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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Sleep Timing and Circadian Preferences in A Sample of Egyptian Patients With Hepatic Cirrhosis
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Group/Cohort Intervention/treatment
liver cirrhosis
Sleep quality, sleep timing parameters and circadian preference were evaluated using (PSQI), (STQ).
Other: (PSQI), (STQ).
Sleep quality, sleep timing parameters and circadian preference were evaluated using (PSQI), (STQ).

control
Sleep quality, sleep timing parameters and circadian preference were evaluated using (PSQI), (STQ).
Other: (PSQI), (STQ).
Sleep quality, sleep timing parameters and circadian preference were evaluated using (PSQI), (STQ).




Primary Outcome Measures :
  1. Number of individuals with sleep disturbances [ Time Frame: 1 year ]
    Number of individuals with sleep disturbances among cirrhotics



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Individuals with hepatic cirrhosis (n=50) and healthy controls (n=30) were recruited.
Criteria

Inclusion Criteria:

  • Liver cirrhosis
  • controls

Exclusion Criteria:

  • HCC

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): NCT02710227


Contacts
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Contact: Sherief Abd-Elsalam, MD 00201095159522 sherif_tropical@yahoo.com

Locations
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Egypt
Tanta university - faculty of medicine Not yet recruiting
Tanta, Elgharbia, Egypt
Contact: Sherief Abdelsalam, lecturer    00201095159522    Sheriefabdelsalam@yahoo.com   
Sponsors and Collaborators
Sherief Abd-Elsalam
Investigators
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Principal Investigator: Mohamed yousef, MD Hepatology and gastroenterology dept.-Tanta
Study Director: Mohamed seleem, MD Neuropsychiatry dept.- Tanta
Study Director: Sherief Abd-Elsalam, MD Hepatology and gastroenterology dept.-Tanta
Study Chair: Mohamed Elhendawy, MD Hepatology and gastroenterology dept.-Tanta
Study Chair: Sabry Abou saif, MD Hepatology and gastroenterology dept.-Tanta
Study Chair: Abdelrahman Kobtan, MD Hepatology and gastroenterology dept.-Tanta

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Responsible Party: Sherief Abd-Elsalam, MD liver diseases, Tanta University
ClinicalTrials.gov Identifier: NCT02710227     History of Changes
Other Study ID Numbers: Sleep Patterns in cirrhotics
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases