NCT02710227

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
2.5 years until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

1.2 years

First QC Date

March 9, 2016

Last Update Submit

June 17, 2017

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Number of individuals with sleep disturbances

    Number of individuals with sleep disturbances among cirrhotics

    1 year

Study Arms (2)

liver cirrhosis

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

Other: (PSQI), (STQ).

control

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

Other: (PSQI), (STQ).

Interventions

(PSQI), (STQ).OTHER

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

controlliver cirrhosis

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Liver cirrhosis
  • controls

You may not qualify if:

  • HCC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university - faculty of medicine

Tanta, Elgharbia, Egypt

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed yousef, MD

    Hepatology and gastroenterology dept.-Tanta

    PRINCIPAL INVESTIGATOR

  • Mohamed seleem, MD

    Neuropsychiatry dept.- Tanta

    STUDY DIRECTOR

  • Sherief Abd-Elsalam, MD

    Hepatology and gastroenterology dept.-Tanta

    STUDY DIRECTOR

  • 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 CHAIR

Central Study Contacts

Sherief Abd-Elsalam, MD

CONTACT

00201095159522sherif_tropical@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD liver diseases

Study Record Dates

First Submitted

March 9, 2016

First Posted

March 16, 2016

Study Start

September 1, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

June 20, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)