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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
8
Active Mattress Cover
Placebo Mattress Cover
UC Irvine-MDA ALS and Neuromuscular Center
Orange, California, United States
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).
Time frame: 14 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed daily for 14 days per intervention.
Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain.
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Secondary outcome: Sleep latency in placebo mattress cover compared to active mattress cover.
Time frame: Assessed daily for 14 days per intervention.