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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Mattress Cover | Active Comparator | Subjects in this arm will be given the placebo mattress cover followed active mattress cover . |
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| Placebo Mattress Cover | Placebo Comparator | Subjects in this arm will be given the active mattress cover followed by the placebo mattress cover. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Mattress Cover | Device | Active Mattress Cover |
| |
| 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 |
| 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. |
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Inclusion Criteria:
You are eligible to participate in this study if you:
Exclusion Criteria:
You are not eligible to participate in this study if you:
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| Name | Affiliation | Role |
|---|---|---|
| Annabel K Wang, MD | UC Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Irvine-MDA ALS and Neuromuscular Center | Orange | California | 92868 | United States |
A total of 8 participants were entered into this crossover study. The total duration of the study was approximately 49 days, including 14 days of screening and 14 days of the first intervention, 7 days of washout, and 14 days of the second intervention.
Recruitment was by advertisement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Mattress Cover First, Then Active Mattress Cover | Subjects were randomly assigned in this crossover double blind designed trial to the placebo mattress cover or active mattress cover for 14 days. |
| FG001 | Active Mattress Cover First, Then Placebo Mattress Cover | Subjects were randomly assigned in this crossover double blind designed trial to the active mattress cover or placebo mattress cover for 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Mattress Cover First, Then Active Mattress Cover | Subjects in this crossover double blind designed trial will be randomized into the placebo mattress cover group for 14 days. After a 7 day washout, they will be entered into the active mattress cover group for 14 days. |
| BG001 | Active Mattress Cover First, Then Placebo Mattress Cover |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The sponsor determined the size of the study. | Posted | Mean | Standard Deviation | units on a scale | 14 days |
|
1 year 2 months (April 2010-June 2011)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Mattress Cover | Subjects will be randomly assigned in this crossover double blind designed trial to the placebo mattress cover for 14 days, followed by the active mattress cover for 14 days after a 7 day wash out period. |
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This is a pilot study to determine the framework to study sleep, pain and mattress covers. The number of subjects is small. The observed data is evaluated in a descriptive (bar graph) presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Seth Casden | Hologenix, LLC | 310-600-3673 | seth.casden@celiant.com |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo Mattress Cover |
| Device |
Placebo Mattress Cover |
|
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. |
Subjects in this crossover double blind designed trial will be randomized into the active mattress cover group for 14 days. After a 7 day washout, they will be entered into the placebo mattress cover group for 14 days. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Mean Clinical Global Impression pain scores with active mattress cover. |
| OG002 | Mean CGI Sleep Scores With Placebo Mattress Cover. | Mean Clinical Global Impression sleep scores with placebo mattress cover. |
| OG003 | Mean CGI Sleep Scores With Active Mattress Cover. | Mean Clinical Global Impression sleep scores with active mattress cover. |
|
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| Secondary | 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. | The sponsor determined the number of participants. | Posted | Mean | Standard Deviation | Minutes | Assessed daily for 14 days per intervention. |
|
|
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| Secondary | 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. | The sponsor determined the number of participants. | Posted | Mean | Standard Deviation | Minutes | Assessed daily for 14 days per intervention. |
|
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| Secondary | 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. | The sponsor determined the number of participants. | Posted | Mean | Standard Deviation | Awakenings | Assessed daily for 14 days per intervention. |
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| Secondary | 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. | The sponsor determined the number of participants. | Posted | Mean | Standard Deviation | Percentage of time asleep | Assessed daily for 14 days per intervention. |
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| Secondary | 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. | The sponsor determined the number of participants. | Posted | Mean | Standard Deviation | Minutes | Assessed daily for 14 days per intervention. |
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| 0 |
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| EG001 | Active Mattress Cover | Subjects will be randomly assigned in this crossover double blind designed trial to the active mattress cover for 14 days, followed by the placebo mattress cover for 14 days after a 7 day wash out period. | 0 | 3 | 0 | 3 |
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| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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