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NCT00482859 Clinical Trial

Sleep Disturbance and Sleep Quality in Women With Fibromyalgia Syndrome

Fibromyalgia Syndrome Clinical Trial

Official title:
Sleep Disturbance and Sleep Quality in Women With Fibromyalgia Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00482859
Other study ID # 07-0188-P2G
Secondary ID Non-Applicable
Status Completed
Phase N/A
First received June 3, 2007
Last updated January 21, 2009
Start date April 2007
Est. completion date April 2008

Study information
Verified date January 2009
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this week long study is to describe sleep and problems with sleep in women diagnosed with Fibromyalgia syndrome.

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.

Recruitment information / eligibility
Status Completed
Enrollment 57
Est. completion date April 2008
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Women 18 years old; diagnosed with Fibromyalgia;

Exclusion Criteria:

- Volunteer works night shift (11PM - 7AM);

- Volunteer has been diagnosed with sleep apnea.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Kentucky
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