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Study of Mattress Type in Fibromyalgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01108718
First Posted: April 22, 2010
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Beth Israel Medical Center
March 23, 2010
April 22, 2010
February 3, 2012
May 31, 2013
March 10, 2017
July 2009
October 2010   (Final data collection date for primary outcome measure)
Mattress Preference of Fibromyalgia Patients [ Time Frame: 6 months ]
Study patients were asked to rate each test mattress after 2 months of use, based on their quality of sleep and severity of symptoms relating to fibromyalgia. The various stages of sleep were monitored via polysomnography(PSG) and scored to indicate the degree to which they reflect a normal sleep pattern. Change in severity of fibromyalgia symptoms were assessed by chi-squared and t-test.
Sleep indices as determined by polysomnography and improvement in a number of tender points. [ Time Frame: 15 months ]
The study is 6 months in duration and is anticipated to be completed within 15 months. Study participants are being reimbursed for their time.
Complete list of historical versions of study NCT01108718 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study of Mattress Type in Fibromyalgia
Study of Mattress Type in Fibromyalgia
The purpose of this research study is to determine if a new mattress relieves the symptoms of fibromyalgia and improves sleep, and if this is the case, whether one type of mattress is better than the other in doing so.
The various stages of sleep will be monitored via polysomnography(PSG) and scored to indicate the degree to which they reflect a normal sleep pattern. Changes in the severity of fibromyalgia symptoms will be assessed by tender point exam and study questionnaires administered at 2 month intervals.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fibromyalgia
  • Other: Tempur-Pedic Mattress (2 months)
    Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first, then the Control Mattress.
  • Other: Control Mattress (2 months)
    Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first, then the Tempur-pedic Mattress.
  • Experimental: Participants: Tempur Pedic first.
    Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder who receive the Tempur-Pedic mattress first, then the Control Mattress.
    Intervention: Other: Tempur-Pedic Mattress (2 months)
  • Placebo Comparator: Participants: Control Mattress first.
    Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first, then the Tempur-pedic mattress.
    Intervention: Other: Control Mattress (2 months)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
July 2011
October 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female subjects who fulfill the American College of Rheumatology's case definition for Fibromyalgia -- that is they have both wide spread pain and more than 10 of the 18 tender points
  • 18 years of age or older
  • Has to be on stable medications and followed by one physician

Exclusion Criteria:

  • Subjects with the existence of an undiagnosed sleep disorder - namely obstructive sleep apnea or periodic leg movement syndrome
  • Pregnancy
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01108718
BIMC 015-09
No
Not Provided
Plan to Share IPD: No
Beth Israel Medical Center
Beth Israel Medical Center
Not Provided
Principal Investigator: Benjamin Natelson, MD Beth Israel Medical Center
Beth Israel Medical Center
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP