Clinical trial NCT02710227: Sleep Timing and Circadian Preferences in A Sample of Egyptian Patients With Hepatic Cirrhosis
Official title: Sleep Timing and Circadian Preferences in A Sample of Egyptian Patients With Hepatic Cirrhosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with hepatic cirrhosis (n=50) and healthy controls (n=30) were recruited.

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

Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis
* controls

Exclusion Criteria:

* HCC

Primary outcomes:
measure: Number of individuals with sleep disturbances
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university - faculty of medicine
state: Elgharbia
Study officials:
affiliation: Hepatology and gastroenterology dept.-Tanta
name: Mohamed yousef, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neuropsychiatry dept.- Tanta
name: Mohamed seleem, MD
role: STUDY_DIRECTOR
affiliation: Hepatology and gastroenterology dept.-Tanta
name: Sherief Abd-Elsalam, MD
role: STUDY_DIRECTOR
affiliation: Hepatology and gastroenterology dept.-Tanta
name: Mohamed Elhendawy, MD
role: STUDY_CHAIR
affiliation: Hepatology and gastroenterology dept.-Tanta
name: Sabry Abou saif, MD
role: STUDY_CHAIR
affiliation: Hepatology and gastroenterology dept.-Tanta
name: Abdelrahman Kobtan, MD
role: STUDY_CHAIR
References: