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: January 11, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 23, 2010

Last Updated Date

January 11, 2012

Start Date ^ICMJE

July 2009

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Sleep indices as determined by polysomnography and improvement in a number of tender points. [ Time Frame: 15 months ] [ Designated as safety issue: No ]

The study is 6 months in duration and is anticipated to be completed within 15 months. Study participants are being reimbursed for their time.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01108718 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Mattress Type in Fibromyalgia

Official Title ^ICMJE

Study of Mattress Type in Fibromyalgia

Brief Summary

Patients with Fibromyalgia using a brand mattress will show greater improvement sleeping than when using a comparison mattress.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Fibromyalgia

Intervention ^ICMJE

Device: Brand name mattress
Used for a two month duration
Device: Comparison mattress
Used for two month duration

Study Arm (s)

Experimental: Patients with Fibromyalgia

Half of the patients with Fibromyalgia will receive the brand mattress followed by the control mattress while half will get the control followed by the Brand mattress.

Interventions:

Device: Brand name mattress
Device: Comparison mattress

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

January 2012

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01108718

Other Study ID Numbers ^ICMJE

BIMC 015-09

Has Data Monitoring Committee

Responsible Party

Beth Israel Medical Center

Study Sponsor ^ICMJE

Beth Israel Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Benjamin Natelson, MD

Beth Israel Medical Center

Information Provided By

Beth Israel Medical Center

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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