Study of Mattress Type in Fibromyalgia

Beth Israel Lahey Health

Status: Completed

Conditions: Fibromyalgia

Treatments: Other: Tempur-Pedic Mattress (2 months); Other: Control Mattress (2 months)

Study type: Interventional

Funder types: Other

Identifiers

NCT01108718

BIMC 015-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups, including a placebo group

Participants: Tempur Pedic first.

Experimental group

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.

Treatment:

Other: Tempur-Pedic Mattress (2 months)

Participants: Control Mattress first.

Placebo Comparator group

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.

Treatment:

Other: Control Mattress (2 months)