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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 did influence back symptoms, function and sleep more positively than did a hard mattress. Pain improves with airbeds compared to regular innerspring mattresses. This study will analyze the effect of optically active particles mattress covers on sleep. The researcher is interested in learning if regular mattress or the study mattress cover (containing optically modified polyethylene terephthalate fiber mattress cover) is more useful in helping back pain and sleep quality.

Official Title
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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

Conditions
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Back Pain, Insomnia

Intervention / Treatment
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* Device: Active Mattress Cover
* Device: Placebo Mattress Cover


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Mattress Cover<br>Subjects in this arm will be given the placebo mattress cover followed active mattress cover . | Device: Active Mattress Cover<br>* Active Mattress Cover<br>|
| Placebo Comparator: Placebo Mattress Cover<br>Subjects in this arm will be given the active mattress cover followed by the placebo mattress cover. | Device: Placebo Mattress Cover<br>* Placebo Mattress Cover<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | The primary outcomes are the change in mean daily Clinical Global Impressions (pain and sleep) in placebo mattress compared to active mattress cover (assessed daily for 14 days per intervention). The daily scores range from 1 (very much improved) to 7 (very much worse). | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain. | Secondary outcome: Nighttime wake-time after sleep onset with placebo mattress cover compared to active mattress cover. | Assessed daily for 14 days per intervention. | 
| Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain. | Secondary outcome: Total sleep time with placebo mattress cover compared to active mattress cover. | Assessed daily for 14 days per intervention. | 
| Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain. | Secondary outcome: Number of nocturnal awakenings with placebo mattress cover compared to active mattress cover. | Assessed daily for 14 days per intervention. | 
| Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain. | Secondary outcome: Sleep efficiency in placebo mattress cover compared to active mattress cover. | Assessed daily for 14 days per intervention. | 
| Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain. | Secondary outcome: Sleep latency in placebo mattress cover compared to active mattress cover. | Assessed daily for 14 days per intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Back Pain, Sleep