Fibromyalgia SyndromeNCT00482859
Sleep Disturbance and Sleep Quality in Women With Fibromyalgia Syndrome
An observational study of Fibromyalgia Syndrome, run by University of Kentucky.
Trial summary
The purpose of this week long study is to describe sleep and problems with sleep in women diagnosed with Fibromyalgia syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia Syndrome
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Apr 2008
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with Fibromyalgia
Who may be able to join
- Women 18 years old; diagnosed with Fibromyalgia;
Who cannot join
- Volunteer works night shift (11PM - 7AM);
- Volunteer has been diagnosed with sleep apnea.
About this study
The purpose of this week long study is to describe sleep and problems with sleep in women diagnosed with Fibromyalgia syndrome.
Read the detailed description
At least 50 women over 18 years of age are invited to volunteer in this study. Sleep quality and problems with sleep will be described using several kinds of measures. Questionnaires on sleep and Fibromyalgia will be completed by the volunteer. In addition, the volunteer will complete a sleep diary for at least 7 days and wear an Actiwatch (a wrist watch like device that measures sleep). At completion of the study, participants will be provided a print out of their sleep obtained from the Actiwatch.
Participants may not be in the study if they work night shift (11 pm - 7 am) or have been diagnosed with a condition called sleep apnea.
Participants need not live in Kentucky to participate in this study.
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Fibromyalgia Syndrome
- Medical subject headings
- Fibromyalgia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study startApr 2007
- Primary completionDec 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Investigators
- Suzette L Sewell, RN MSN, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482859
- Sponsor's protocol ID
- 07-0188-P2G
- Other IDs
- Non-Applicable
- Status last verified
- Jan 2009
- First submitted
- 3 Jun 2007
- Last updated
- 22 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disturbance and Sleep Quality in Women With Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT00482859
- Acronym / sponsor ID
- 07-0188-P2G
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Fibromyalgia Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 5 Jun 2007 (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 week long study is to describe sleep and problems with sleep in women diagnosed with Fibromyalgia syndrome.
Detailed description
At least 50 women over 18 years of age are invited to volunteer in this study. Sleep quality and problems with sleep will be described using several kinds of measures. Questionnaires on sleep and Fibromyalgia will be completed by the volunteer. In addition, the volunteer will complete a sleep diary for at least 7 days and wear an Actiwatch (a wrist watch like device that measures sleep). At completion of the study, participants will be provided a print out of their sleep obtained from the Actiwatch.
Participants may not be in the study if they work night shift (11 pm - 7 am) or have been diagnosed with a condition called sleep apnea.
Participants need not live in Kentucky to participate in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with Fibromyalgia
Key inclusion criteria (1 listed)
- Women 18 years old; diagnosed with Fibromyalgia;
Key exclusion criteria (2 listed)
- Volunteer works night shift (11PM - 7AM);
- Volunteer has been diagnosed with sleep apnea.
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
Not reported in the source record.
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 22 Jan 2009.
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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.
Suzette L Sewell, RN MSN principal investigator
University of Kentucky
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia Syndrome, run by University of Kentucky.
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 2 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 22 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
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 22 Jan 2009.