DystoniaFIDNCT00954408
Fatigue in Dystonia (a Single Session, Questionnaire-based Study of Fatigue in Dystonia)
An observational study of Dystonia, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to determine how common fatigue and sleepiness are in patients with dystonia. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Dystonia
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Current dystonia patients in our clinic between the ages of 21 and 100.
Who may be able to join
- Informed consent to be contacted about research
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Movement Disorders Center
Gainesville, Florida, 32605
About this study
Official title: Fatigue in Dystonia (IRB No. 108-2008)
The purpose of this study is to determine how common fatigue and sleepiness are in patients with dystonia.
Read the 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.
- Conditions
- Dystonia
- Medical subject headings
- Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with dystonia | Patients with dystonia, 21-100 years of age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the prevalence of fatigue and sleepiness in patients with dystonia.
Measured: At the time of their visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystoniaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael S Okun, M.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954408
- Sponsor's protocol ID
- 108-2008
- Acronym
- FID
- Status last verified
- Apr 2024
- First submitted
- 5 Aug 2009
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue in Dystonia (IRB No. 108-2008)
- ClinicalTrials.gov ID
- NCT00954408
- Acronym / sponsor ID
- FID / 108-2008
- Conditions
- Dystonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 7 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine how common fatigue and sleepiness are in patients with dystonia.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with dystonia | – | –Patients with dystonia, 21-100 years of age. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Current dystonia patients in our clinic between the ages of 21 and 100.
Key inclusion criteria (1 listed)
- Informed consent to be contacted about research
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the prevalence of fatigue and sleepiness in patients with dystonia.
Time frame: At the time of their visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael S Okun, M.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dystonia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the prevalence of fatigue and sleepiness in patients with dystonia. (time frame: At the time of their visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.