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: June 10, 2013
Last verified: June 2013
Results First Received: February 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Fibromyalgia
Interventions: Other: Tempur-Pedic Mattress (2 months)
Other: Control Mattress (2 months)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients from Dr. Natelson's clinical practice at Beth Israel Medical Center in New York who fulfilled the 1990 case definition for fibromyalgia.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who displayed the existence of a previously undiagnosed sleep disorder were excluded from study participation.

Reporting Groups
  Description
Subjects Who Received the Tempur-Pedic Mattress First 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.
Subjects Who Recieved the 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.

Participant Flow for 2 periods

Period 1:   Received Tempur-Pedic (2 Months)
    Subjects Who Received the Tempur-Pedic Mattress First     Subjects Who Recieved the Control Mattress First  
STARTED     5     7  
COMPLETED     5     7  
NOT COMPLETED     0     0  

Period 2:   Recieved Control (2 Months)
    Subjects Who Received the Tempur-Pedic Mattress First     Subjects Who Recieved the Control Mattress First  
STARTED     4     7  
COMPLETED     4     7  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Subjects Who Receive Tempur-Pedic Mattress First(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.
Subjects Who Recieve the Control Mattress First(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.
Total Total of all reporting groups

Baseline Measures
    Subjects Who Receive Tempur-Pedic Mattress First(2 Months)     Subjects Who Recieve the Control Mattress First(2 Months)     Total  
Number of Participants  
[units: participants]
  5     7     12  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     5     7     12  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     5     7     12  
Male     0     0     0  



  Outcome Measures

1.  Primary:   Mattress Preference of Fibromyalgia Patients   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Diana Vu
Organization: Beth Israel Medical Center
phone: 212-844-6747
e-mail: dvu@bethisraelny.org


No publications provided


Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01108718     History of Changes
Other Study ID Numbers: BIMC 015-09
Study First Received: March 23, 2010
Results First Received: February 3, 2012
Last Updated: June 10, 2013
Health Authority: United States: Institutional Review Board