NCT01002001

Brief 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).

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 27, 2009

Status Verified

October 1, 2009

Enrollment Period

1.2 years

First QC Date

October 26, 2009

Last Update Submit

October 26, 2009

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Sleep disturbances in patients with advanced cirrhosis

    18 months

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients attending the pre and post-transplantation liver clinics

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • George Therapondos, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 27, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 27, 2009

Record last verified: 2009-10

Locations

CA(1)