Study of Mattress Type in Fibromyalgia

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Other: Tempur-Pedic Mattress (2 months); Other: Control Mattress (2 months)

• Registration Number: NCT01108718
• Lead Sponsor: Beth Israel Medical Center

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-03-23
• Study First Submitted QC: 2010-04-21
• Study First Posted: 2010-04-22
• Primary Completion: 2010-10
• Study Completion: 2011-07
• Results First Submitted: 2012-02-03
• Results First Submitted QC: 2013-04-25
• Results First Posted: 2013-05-31
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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

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Exclusion Criteria

• Subjects with the existence of an undiagnosed sleep disorder - namely obstructive sleep apnea or periodic leg movement syndrome
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Participants: Tempur Pedic first.	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 who receive the Tempur-Pedic mattress first, then the Control Mattress.
Participants: Control Mattress first.	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.

Primary Outcome Measures

Name	Time	Method
Mattress Preference of Fibromyalgia Patients	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.

Trial Locations

Locations (1)

Pain and Fatigue Study Center - Beth Israel Medical Center; 🇺🇸 New York, New York, United States