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

NCT ID: NCT00969540

Last Updated: 2014-12-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-07-31

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.

Conditions

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Back Pain Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active Mattress Cover

Subjects in this arm will be given the placebo mattress cover followed active mattress cover .

Group Type ACTIVE_COMPARATOR

Active Mattress Cover

Intervention Type DEVICE

Active Mattress Cover

Placebo Mattress Cover

Subjects in this arm will be given the active mattress cover followed by the placebo mattress cover.

Group Type PLACEBO_COMPARATOR

Placebo Mattress Cover

Intervention Type DEVICE

Placebo Mattress Cover

Interventions

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Active Mattress Cover

Active Mattress Cover

Intervention Type DEVICE

Placebo Mattress Cover

Placebo Mattress Cover

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Annabel Kim Wang

Associate Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Annabel K Wang, MD

Role: PRINCIPAL_INVESTIGATOR

UC Irvine

Locations

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UC Irvine-MDA ALS and Neuromuscular Center

Orange, California, United States

Site Status

Countries

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United States

Other Identifiers

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mattress1

Identifier Type: -

Identifier Source: org_study_id