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

• Conditions: Liver Cirrhosis
• Interventions: Other: (PSQI), (STQ).

• Registration Number: NCT02710227
• Lead Sponsor: Sherief Abd-Elsalam

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

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 Timeline

• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-16
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-17
• Last Update Posted: 2017-06-20
• Study Start: 2018-09
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Liver cirrhosis
• controls

Exclusion Criteria

• HCC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
liver cirrhosis	(PSQI), (STQ).	Sleep quality, sleep timing parameters and circadian preference were evaluated using (PSQI), (STQ).
control	(PSQI), (STQ).	Sleep quality, sleep timing parameters and circadian preference were evaluated using (PSQI), (STQ).

Primary Outcome Measures

Name	Time	Method
Number of individuals with sleep disturbances	1 year	Number of individuals with sleep disturbances among cirrhotics

Trial Locations

Locations (1)

Tanta university - faculty of medicine; 🇪🇬 Tanta, Elgharbia, Egypt