Trial on the Effect of Optically Modified Fiber Mattress Covers on Sleep Disturbances in Patients With Chronic Back Pain
CompletedNot applicableNCT00969540
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Double Blind, Placebo Controlled, Crossover Pilot Trial on the Effect of Optically Modified Polyethylene Terephthalate Fiber Mattress Covers on Sleep Disturbances in Patients With Chronic Back Pain
- Interventions
- Device: Active Mattress Cover
- Device: Placebo Mattress Cover
- Sponsor
- University of California, Irvine
- Start date
- 2009-06
- Primary completion
- 2011-07
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: You are eligible to participate in this study if you: 1. have a clinical diagnosis of chronic lower back pain 2. have pain measured on the Visual Analogue scale 3. have sleep disturbances at night associated with chronic lower back pain 4. are 18 years or older 5. sign the written, informed consent form prior to the initiation of any study procedures 6. have an habitual bedtime between 8 P.M. and 12 A.M. 7. are on a stable pain management regime Exclusion Criteria: You are not eligible to participate in this study if you: 1. are unwilling or unable to comply with the protocol or scheduled appointments 2. are unable to understand the language in which the approved informed consent is written 3. have no pain measured on the Visual Analogue scale 4. are unable to walk, wheel chair bound or confined to bed 5. 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 6. lack a mobile arm to which to attach an actigraphy. 7. are currently participate or participated in another clinical study within the past 30 days 8. 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 9. use tobacco products or any other products during nightly awakenings that may interfere with the sleep wake cycle 10. 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00969540