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

NCT ID: NCT02710227

Last Updated: 2017-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-30

Study Completion Date

2019-12-31

Brief Summary

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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

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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

Conditions

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Liver Cirrhosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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liver cirrhosis

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

(PSQI), (STQ).

Intervention Type OTHER

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).

(PSQI), (STQ).

Intervention Type OTHER

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

Interventions

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(PSQI), (STQ).

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Liver cirrhosis
* controls

Exclusion Criteria

* HCC
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sherief Abd-Elsalam

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

MD liver diseases

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mohamed yousef, MD

Role: PRINCIPAL_INVESTIGATOR

Hepatology and gastroenterology dept.-Tanta

Mohamed seleem, MD

Role: STUDY_DIRECTOR

Neuropsychiatry dept.- Tanta

Sherief Abd-Elsalam, MD

Role: STUDY_DIRECTOR

Hepatology and gastroenterology dept.-Tanta

Mohamed Elhendawy, MD

Role: STUDY_CHAIR

Hepatology and gastroenterology dept.-Tanta

Sabry Abou saif, MD

Role: STUDY_CHAIR

Hepatology and gastroenterology dept.-Tanta

Abdelrahman Kobtan, MD

Role: STUDY_CHAIR

Hepatology and gastroenterology dept.-Tanta

Locations

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Tanta university - faculty of medicine

Tanta, Elgharbia, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Sherief Abd-Elsalam, MD

Role: CONTACT

00201095159522

Facility Contacts

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Sherief Abdelsalam, lecturer

Role: primary

00201095159522

Other Identifiers

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Sleep Patterns in cirrhotics

Identifier Type: -

Identifier Source: org_study_id

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