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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02710227
• Other study ID #: Sleep Patterns in cirrhotics
• Status: Not yet recruiting
• Phase: N/A
• First received: March 9, 2016
• Last updated: June 17, 2017
• Start date: September 2018
• Est. completion date: December 2019

Study information

• Verified date: June 2017
• Source: Tanta University
• Contact: Sherief Abd-Elsalam, MD
• Phone: 00201095159522
• Email: sherif_tropical[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Liver cirrhosis

• controls

Exclusion Criteria:

• HCC

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

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

Locations

Country	Name	City	State
Egypt	Tanta university - faculty of medicine	Tanta	Elgharbia

Sponsors (1)

Lead Sponsor	Collaborator
Sherief Abd-Elsalam

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of individuals with sleep disturbances	Number of individuals with sleep disturbances among cirrhotics	1 year