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Study of Mattress Type in Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tempur-Pedic Mattress (2 months)
Control Mattress (2 months)
Sponsored by
Beth Israel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Mattress, Tempur-Pedic, Fibromyalgia, Sleep patterns

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pain and Fatigue Study Center - Beth Israel Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Participants: Tempur Pedic first.

Participants: Control Mattress first.

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mattress Preference of Fibromyalgia Patients
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.

Secondary Outcome Measures

Full Information

First Posted
March 23, 2010
Last Updated
January 30, 2017
Sponsor
Beth Israel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01108718
Brief Title
Study of Mattress Type in Fibromyalgia
Official Title
Study of Mattress Type in Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Mattress, Tempur-Pedic, Fibromyalgia, Sleep patterns

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants: Tempur Pedic first.
Arm Type
Experimental
Arm Description
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.
Arm Title
Participants: Control Mattress first.
Arm Type
Placebo Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Tempur-Pedic Mattress (2 months)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Mattress (2 months)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mattress Preference of Fibromyalgia Patients
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Natelson, MD
Organizational Affiliation
Beth Israel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain and Fatigue Study Center - Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10014
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.painandfatigue.com
Description
The Pain and Fatigue Study Center

Learn more about this trial

Study of Mattress Type in Fibromyalgia

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