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NCT01002001 Clinical Trial

Sleep Disorders Pre and Post Liver Transplantation

Liver Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT01002001
Other study ID # REB 09-0459
Secondary ID
Status Enrolling by invitation
Phase N/A
First received October 26, 2009
Last updated October 26, 2009
Start date October 2009
Est. completion date December 2010

Study information
Verified date October 2009
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 200
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Toronto General Hospital Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sleep disturbances in patients with advanced cirrhosis 18 months No
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