FibromyalgiaNCT01108718

Study of Mattress Type in Fibromyalgia

A study testing Tempur-Pedic Mattress (2 months) in people with Fibromyalgia, run by Beth Israel Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Fibromyalgia
What is being tested?: Tempur-Pedic Mattress (2 months)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Jul 2009to Jul 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Pain and Fatigue Study Center - Beth Israel Medical Center
New York, New York, 10014

Other trials in United States

About this study

Read the detailed 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.

Conditions: Fibromyalgia
Being tested: Tempur-Pedic Mattress (2 months), Control Mattress (2 months)
Keywords: Mattress, Tempur-Pedic, Fibromyalgia, Sleep patterns
Medical subject headings: Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
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.

Study groups in NCT01108718
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Control Mattress (2 months)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Jul 2011

First posted22 Apr 2010 (estimated)
Study startJul 2009
Primary completionOct 2010
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01108718
Sponsor's protocol ID: BIMC 015-09
Status last verified: Jan 2017
First submitted: 23 Mar 2010
Last updated: 10 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Mattress Type in Fibromyalgia
ClinicalTrials.gov ID: NCT01108718
Acronym / sponsor ID: BIMC 015-09
Conditions: Fibromyalgia
Keywords: Mattress, Tempur-Pedic, Fibromyalgia, Sleep patterns
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Beth Israel Medical CenterUniversity, hospital or other
Study start: Jul 2009
Primary completion: Oct 2010 (actual)
Study completion: Jul 2011 (actual)
First posted: 22 Apr 2010 (estimated)
Results: Posted 31 May 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Participants: Tempur Pedic first.	Experimental	Other: Tempur-Pedic Mattress (2 months)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.
Participants: Control Mattress first.	Placebo comparator	Other: Control Mattress (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, then the Tempur-pedic mattress.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tempur-Pedic Mattress (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, then the Control Mattress.	Other	Participants: Tempur Pedic first.
Control Mattress (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, then the Tempur-pedic Mattress.	Other	Participants: Control Mattress first.

Primary outcome

Mattress Preference of Fibromyalgia Patients
Time frame: 6 months
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.

Results and safety

Results posted to the registry on 31 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects Who Received the Tempur-Pedic Mattress First	5	5
Subjects Who Received the Control Mattress First	7	7

Primary outcome: Mattress Preference of Fibromyalgia Patients

Time frame: 6 months. Number. Unit: percentage of study participants

Measure	All Participants n = 11
Tempur-Pedic Mattress	45 (5 to 95)
Control Mattress	55
No Preference	0

All Participants: Rate of Preference: .45 (95% CI .43 to .47), p >0.1, McNemar

Population analysed: 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.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects Who Received Tempur-Pedic Mattress First	0 of 5 (0%)	1 of 5 (20%)	Not reported
Subjects Who Received the Control Mattress First	0 of 7 (0%)	0 of 7 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
The Pain and Fatigue Study CenterLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Fibromyalgia

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Benjamin Natelson, MD principal investigator

Beth Israel Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Tempur-Pedic Mattress (2 months) in people with Fibromyalgia, run by Beth Israel Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mattress Preference of Fibromyalgia Patients (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01108718.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017.