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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00954408
First Posted: August 7, 2009
Last Update Posted: September 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
  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. ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00954408     History of Changes
Other Study ID Numbers: 108-2008
First Submitted: August 5, 2009
First Posted: August 7, 2009
Last Update Posted: September 19, 2011
Last Verified: August 2011

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