Status:
COMPLETED
Trial on the Effect of Optically Modified Fiber Mattress Covers on Sleep Disturbances in Patients With Chronic Back Pain
Lead Sponsor:
University of California, Irvine
Conditions:
Back Pain
Insomnia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Sleep quantity and quality can be influenced by the type of mattress used. This study is being done to see if a mattress cover with optically active particles can help back pain and improve sleep qual...
Detailed Description
It is commonly observed that sleep in its quantity and quality is influenced by the type of mattress used at night. A recent study in patients with back pain showed that waterbeds and foam mattresses ...
Eligibility Criteria
Inclusion
- You are eligible to participate in this study if you:
- have a clinical diagnosis of chronic lower back pain
- have pain measured on the Visual Analogue scale
- have sleep disturbances at night associated with chronic lower back pain
- are 18 years or older
- sign the written, informed consent form prior to the initiation of any study procedures
- have an habitual bedtime between 8 P.M. and 12 A.M.
- are on a stable pain management regime
Exclusion
- You are not eligible to participate in this study if you:
- are unwilling or unable to comply with the protocol or scheduled appointments
- are unable to understand the language in which the approved informed consent is written
- have no pain measured on the Visual Analogue scale
- are unable to walk, wheel chair bound or confined to bed
- are deemed by the investigator to be unreliable to wear the actigraphy, to complete the sleep log, to use the provided mattress covers at the proper time, to come to the scheduled visits or to answer questions regarding the subject's condition or medication use
- lack a mobile arm to which to attach an actigraphy.
- are currently participate or participated in another clinical study within the past 30 days
- demonstrate an unwillingness to comply with the maximum limit of two alcoholic drinks per day and only 1 alcoholic drink after 6:00 P.M. for the duration of the protocol
- use tobacco products or any other products during nightly awakenings that may interfere with the sleep wake cycle
- have any unstable medical condition as determined by the investigator, or any other serious disease or condition that might affect life expectancy or make it difficult to successfully manage and follow the subject according to the protocol
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00969540
Start Date
June 1 2009
End Date
July 1 2011
Last Update
December 3 2014
Active Locations (1)
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1
UC Irvine-MDA ALS and Neuromuscular Center
Orange, California, United States, 92868