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Study of Mattress Type in Fibromyalgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT01108718
First received: March 23, 2010
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Fibromyalgia
Other: Tempur-Pedic Mattress (2 months)
Other: Control Mattress (2 months)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Mattress Type in Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:
  • Mattress Preference of Fibromyalgia Patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 12
Study Start Date: July 2009
Study Completion Date: July 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Study patients receiving Tempur-Pedic Mattress 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.
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.
Study patients who recieve the 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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01108718

Locations
United States, New York
Pain and Fatigue Study Center - Beth Israel Medical Center
New York, New York, United States, 10014
Sponsors and Collaborators
Beth Israel Medical Center
Investigators
Principal Investigator: Benjamin Natelson, MD Beth Israel Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01108718     History of Changes
Other Study ID Numbers: BIMC 015-09
Study First Received: March 23, 2010
Results First Received: February 3, 2012
Last Updated: June 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Medical Center:
Mattress
Tempur-Pedic
Fibromyalgia
Sleep patterns

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014