NCT01108718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 22, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 31, 2013

Completed
Last Updated

March 10, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

March 23, 2010

Results QC Date

February 3, 2012

Last Update Submit

January 30, 2017

Conditions

Fibromyalgia

Keywords

MattressTempur-PedicFibromyalgiaSleep patterns

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Study Arms (2)

Participants: Tempur Pedic first.

EXPERIMENTAL

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.

Other: Tempur-Pedic Mattress (2 months)

Participants: Control Mattress first.

PLACEBO COMPARATOR

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.

Other: Control Mattress (2 months)

Interventions

Tempur-Pedic Mattress (2 months)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: Tempur Pedic first.
Control Mattress (2 months)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.

Participants: Control Mattress first.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years of age or older
  • Has to be on stable medications and followed by one physician

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain and Fatigue Study Center - Beth Israel Medical Center

New York, New York, 10014, United States

Location

Related Links

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Results Point of Contact

Title
Diana Vu
Organization
Beth Israel Medical Center
dvu@bethisraelny.org
212-844-6747

Study Officials

  • Benjamin Natelson, MD

    Beth Israel Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2010

First Posted

April 22, 2010

Study Start

July 1, 2009

Primary Completion

October 1, 2010

Study Completion

July 1, 2011

Last Updated

March 10, 2017

Results First Posted

May 31, 2013

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)