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

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

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhosis
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• Egypt
  • Elgharbia
    • Tanta, Elgharbia, Egypt
      • Tanta university - faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Individuals with hepatic cirrhosis (n=50) and healthy controls (n=30) were recruited.

Description

Inclusion Criteria:

• Liver cirrhosis
• controls

Exclusion Criteria:

• HCC

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of individuals with sleep disturbances	Number of individuals with sleep disturbances among cirrhotics	1 year

Collaborators and Investigators

• Sponsor: Sherief Abd-Elsalam
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: March 9, 2016
• First Submitted That Met QC Criteria: March 15, 2016
• First Posted (Estimate): March 16, 2016

Study Record Updates

• Last Update Posted (Actual): June 20, 2017
• Last Update Submitted That Met QC Criteria: June 17, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: Sleep Patterns in cirrhotics

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No