Fatigue in Dystonia (a Single Session, Questionnaire-based Study of Fatigue in Dystonia) (FID)
| Tracking Information | |||||
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| First Received Date ICMJE | August 5, 2009 | ||||
| Last Updated Date | September 16, 2011 | ||||
| Start Date ICMJE | July 2009 | ||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00954408 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Fatigue in Dystonia (a Single Session, Questionnaire-based Study of Fatigue in Dystonia) | ||||
| Official Title ICMJE | Fatigue in Dystonia (IRB No. 108-2008) | ||||
| Brief Summary | The purpose of this study is to determine how common fatigue and sleepiness are in patients with dystonia. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Current dystonia patients in our clinic between the ages of 21 and 100. |
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| Condition ICMJE | Dystonia | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Patients with dystonia
Patients with dystonia, 21-100 years of age. |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 123 | ||||
| Completion Date | July 2011 | ||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: diagnosis of dystonia
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00954408 | ||||
| Other Study ID Numbers ICMJE | 108-2008 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of Florida | ||||
| Study Sponsor ICMJE | University of Florida | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Florida | ||||
| Verification Date | August 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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