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Study of Mattress Type in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT01108718
Recruitment Status : Completed
First Posted : April 22, 2010
Results First Posted : May 31, 2013
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Beth Israel Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Fibromyalgia
Interventions Other: Tempur-Pedic Mattress (2 months)
Other: Control Mattress (2 months)
Enrollment 12
Recruitment Details Patients from Principal Investigator's clinical practice at Beth Israel Medical Center in New York who fulfilled the 1990 case definition for fibromyalgia.
Pre-assignment Details Subjects who displayed the existence of a previously undiagnosed sleep disorder were excluded from study participation.
Arm/Group Title Subjects Who Received the Tempur-Pedic Mattress First Subjects Who Received the Control Mattress First
Hide Arm/Group Description 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. 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.
Period Title: Received First Intervention (2 Months)
Started 5 7
Completed 5 7
Not Completed 0 0
Period Title: Received Second Intervention (2 Months)
Started 5 [1] 7
Completed 4 7
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
[1]
Used control mattress was delivered to participant at crossover causing her to withdraw.
Arm/Group Title Subjects Who Receive Tempur-Pedic Mattress First(2 Months) Subjects Who Receive the Control Mattress First(2 Months) Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 5 7 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 7 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
7
 100.0%
12
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 7 participants 12 participants
Female
5
 100.0%
7
 100.0%
12
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Mattress Preference of Fibromyalgia Patients
Hide Description 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.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Following 2 months use of each test mattress, the study patients' sleep patterns and severity of fibromyalgia symptoms were assessed. At the end of the study, study patients were asked to rate each mattress in order of preference.
Arm/Group Title All Participants
Hide Arm/Group Description:
All subjects used a tempur-pedic mattress and control mattress to sleep on in a cross over design for a period of 2 months per mattress.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: percentage of study participants
Tempur-Pedic Mattress 45
Control Mattress 55
No Preference 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments h0: Rate Preference Tempur-pedic mattress = Rate Preference control mattress h1: Rate Preference Tempur-pedic mattress = Rate Preference control mattress
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.1
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate of Preference
Estimated Value .45
Confidence Interval (2-Sided) 95%
.43 to .47
Parameter Dispersion
Type: Standard Deviation
Value: .5
Estimation Comments Rate of preference refers specifically to Tempur-Pedic Mattress.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Subjects Who Received Tempur-Pedic Mattress First Subjects Who Received the Control Mattress First
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Subjects Who Received Tempur-Pedic Mattress First Subjects Who Received the Control Mattress First
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Subjects Who Received Tempur-Pedic Mattress First Subjects Who Received the Control Mattress First
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Subjects Who Received Tempur-Pedic Mattress First Subjects Who Received the Control Mattress First
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      0/7 (0.00%)    
Investigations     
Subject's own Mattress Discarded * [1]  1/5 (20.00%)  1 0/7 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Subject became upset after her own mattress was mistakenly discarded during the study. Subject withdrew from the study.
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.
Results Point of Contact
Name/Title: Diana Vu
Organization: Beth Israel Medical Center
Phone: 212-844-6747
Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01108718     History of Changes
Other Study ID Numbers: BIMC 015-09
First Submitted: March 23, 2010
First Posted: April 22, 2010
Results First Submitted: February 3, 2012
Results First Posted: May 31, 2013
Last Update Posted: March 10, 2017