Trials / Completed
CompletedNCT01108718
Study of Mattress Type in Fibromyalgia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Beth Israel Medical Center · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 receiving the Tempur-Pedic mattress first, then the Control Mattress. |
| 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. |
Timeline
- Start date
- 2009-07-01
- Primary completion
- 2010-10-01
- Completion
- 2011-07-01
- First posted
- 2010-04-22
- Last updated
- 2017-03-10
- Results posted
- 2013-05-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01108718. Inclusion in this directory is not an endorsement.