Trial on the Effect of Optically Modified Fiber Mattress Covers on Sleep Disturbances in Patients With Chronic Back Pain

Completed · Not applicable · Has a placebo group

Conditions studied: Back Pain, Insomnia

In brief

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 quality.

Key facts

Study ID

NCT00969540

Run by

University of California, Irvine

People needed

8

Starts

2009-06-01

Expected to finish

2011-07-01

Last updated by the study team

2014-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UC Irvine-MDA ALS and Neuromuscular Center — Orange, California, United States

Full record on ClinicalTrials.gov

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