Sleep Disturbance and Sleep Quality in Women With Fibromyalgia Syndrome

This study has been completed.
Sponsor:
Information provided by:
University of Kentucky
ClinicalTrials.gov Identifier:
NCT00482859
First received: June 3, 2007
Last updated: January 21, 2009
Last verified: January 2009
  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

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

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Suzette L. Sewell Scheuermann RN, University of Kentucky College of Nursing
ClinicalTrials.gov Identifier: NCT00482859     History of Changes
Other Study ID Numbers: 07-0188-P2G, Non-Applicable
Study First Received: June 3, 2007
Last Updated: January 21, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
Fibromyalgia Syndrome

Additional relevant MeSH terms:
Syndrome
Fibromyalgia
Myofascial Pain Syndromes
Dyssomnias
Sleep Disorders
Parasomnias
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014