Sleep Disturbance and Sleep Quality in Women With Fibromyalgia Syndrome - Full Text View

Sponsored by:	University of Kentucky
Information provided by:	University of Kentucky
ClinicalTrials.gov Identifier:	NCT00482859

Purpose

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

Condition
Fibromyalgia Syndrome

MedlinePlus related topics: Fibromyalgia Sleep Disorders

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Sleep Disturbance and Sleep Quality in Women With Fibromyalgia Syndrome

Further study details as provided by University of Kentucky:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	57
Study Start Date:	April 2007
Study Completion Date:	April 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Women with Fibromyalgia

Criteria

Inclusion Criteria:

Women 18 years old; diagnosed with Fibromyalgia;

Exclusion Criteria:

Volunteer works night shift (11PM - 7AM);
Volunteer has been diagnosed with sleep apnea.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482859

Sponsors and Collaborators

University of Kentucky

Investigators

Principal Investigator:

Suzette L Sewell, RN MSN

University of Kentucky

More Information

Responsible Party:	University of Kentucky College of Nursing ( Suzette L. Sewell Scheuermann RN )
Study ID Numbers:	07-0188-P2G, Non-Applicable
Study First Received:	June 3, 2007
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00482859
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Kentucky:

Fibromyalgia Syndrome

Study placed in the following topic categories:

Signs and Symptoms
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Mental Disorders
Myofascial Pain Syndromes

Fibromyalgia
Neurologic Manifestations
Dyssomnias
Sleep Disorders
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009