Fatigue in Dystonia (a Single Session, Questionnaire-based Study of Fatigue in Dystonia) (FID)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00954408
First received: August 5, 2009
Last updated: September 16, 2011
Last verified: August 2011
  Purpose

The purpose of this study is to determine how common fatigue and sleepiness are in patients with dystonia.


Condition
Dystonia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Fatigue in Dystonia (IRB No. 108-2008)

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • To determine the prevalence of fatigue and sleepiness in patients with dystonia. [ Time Frame: At the time of their visit. ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: July 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with dystonia
Patients with dystonia, 21-100 years of age.

Detailed Description:

The purpose of the study is to determine the prevalence of fatigue in patients with dystonia. There are many factors which may impact fatigue but perhaps the most important of these is sleep. It is therefore critical that we collect data on sleep habits and sleepiness to help interpret our data on fatigue. We will be using the Epworth Sleepiness Scale to assess daytime somnolence and the Parkinson's Disease Sleep Scale to assess the presence or absence of common sleep disorders affecting patients with movement disorders along with the Multidimensional Fatigue Inventory and the Fatigue Severity Scale.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Current dystonia patients in our clinic between the ages of 21 and 100.

Criteria

Inclusion Criteria: diagnosis of dystonia

  • Informed consent to be contacted about research

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954408

Locations
United States, Florida
University of Florida Movement Disorders Center
Gainesville, Florida, United States, 32605
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Michael S Okun, M.D. University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00954408     History of Changes
Other Study ID Numbers: 108-2008
Study First Received: August 5, 2009
Last Updated: September 16, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Fatigue
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on July 31, 2014