Sleep Disorders Pre and Post Liver Transplantation

October 26, 2009 updated by: University Health Network, Toronto

Prospective Study to Evaluate Sleep Disturbance in Patients With Liver Disease Pre and Post Liver Transplantation

Sleep disturbance and sexual dysfunction are common complaints of patients with cirrhosis . The term sleep disturbance describes insomnia, poor quality sleep, circadian rhythm disorders and obstructive sleep apnea and is associated with reduced health-related quality of life (HRQoL) score indices. Sleep and sexual disorders have only been formally evaluated in small studies in these patients and to date, no studies have objectively assessed these patients. In addition, no studies have been performed in these patients after liver transplantation. The investigators' hypothesis is that sleep and sexual disturbance is commonly seen in patients with advanced cirrhosis and improves after liver transplantation. However, despite this, HRQoL remain impaired because of residual sleep disturbance.This study will be unique in providing cross-sectional follow-up of patients with cirrhosis at baseline and after liver transplantation (> 6 months).

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
        • Toronto General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients attending the pre and post-transplantation liver clinics

Description

Inclusion Criteria:

  • Liver cirrhosis
  • Comprehend and read English
  • On liver transplantation list or post-liver transplantation

Exclusion Criteria:

  • Non-English speaking
  • < 18 years and > 85 yrs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sleep disturbances in patients with advanced cirrhosis
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: George Therapondos, MD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

October 26, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Estimate)

October 27, 2009

Last Update Submitted That Met QC Criteria

October 26, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB 09-0459

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Cirrhosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe