Study of Mattress Type in Fibromyalgia

NCT ID: NCT01108718

Last Updated: 2017-03-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-07-31

Brief Summary

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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

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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.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Tempur-Pedic Mattress (2 months)

Intervention Type OTHER

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.

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.

Group Type PLACEBO_COMPARATOR

Control Mattress (2 months)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin Natelson, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Medical Center

Locations

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Pain and Fatigue Study Center - Beth Israel Medical Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.painandfatigue.com

The Pain and Fatigue Study Center

Other Identifiers

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BIMC 015-09

Identifier Type: -

Identifier Source: org_study_id

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