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

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ClinicalTrials.gov Identifier: NCT00969540
Recruitment Status : Completed
First Posted : September 1, 2009
Results First Posted : December 3, 2014
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Annabel Kim Wang, University of California, Irvine

Tracking Information
First Submitted Date  ICMJE August 31, 2009
First Posted Date  ICMJE September 1, 2009
Results First Submitted Date  ICMJE June 29, 2012
Results First Posted Date  ICMJE December 3, 2014
Last Update Posted Date December 3, 2014
Study Start Date  ICMJE June 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2014)
Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). [ Time Frame: 14 days ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2009)
OMPETFMC improves sleep quality in patients with lower back pain as measured by Clinical Global Impression (CGI) [ Time Frame: 8 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2014)
  • Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain. [ Time Frame: Assessed daily for 14 days per intervention. ]
    Secondary outcome: Nighttime wake-time after sleep onset with placebo mattress cover compared to active mattress cover.
  • Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain. [ Time Frame: Assessed daily for 14 days per intervention. ]
    Secondary outcome: Total sleep time with placebo mattress cover compared to active mattress cover.
  • Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain. [ Time Frame: Assessed daily for 14 days per intervention. ]
    Secondary outcome: Number of nocturnal awakenings with placebo mattress cover compared to active mattress cover.
  • Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain. [ Time Frame: Assessed daily for 14 days per intervention. ]
    Secondary outcome: Sleep efficiency in placebo mattress cover compared to active mattress cover.
  • Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain. [ Time Frame: Assessed daily for 14 days per intervention. ]
    Secondary outcome: Sleep latency in placebo mattress cover compared to active mattress cover.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2009)
Mattress covers improves sleep variables measured with actigraphy in patients with lower back pain Safety and tolerability (via AE, PE, vital signs) of mattress covers [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial on the Effect of Optically Modified Fiber Mattress Covers on Sleep Disturbances in Patients With Chronic Back Pain
Official Title  ICMJE 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
Brief Summary 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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Back Pain
  • Insomnia
Intervention  ICMJE
  • Device: Active Mattress Cover
    Active Mattress Cover
  • Device: Placebo Mattress Cover
    Placebo Mattress Cover
Study Arms  ICMJE
  • Active Comparator: Active Mattress Cover
    Subjects in this arm will be given the placebo mattress cover followed active mattress cover .
    Intervention: Device: Active Mattress Cover
  • Placebo Comparator: Placebo Mattress Cover
    Subjects in this arm will be given the active mattress cover followed by the placebo mattress cover.
    Intervention: Device: Placebo Mattress Cover
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2014)
8
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2009)
6
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00969540
Other Study ID Numbers  ICMJE mattress1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Annabel Kim Wang, University of California, Irvine
Study Sponsor  ICMJE University of California, Irvine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Annabel K Wang, MD UC Irvine
PRS Account University of California, Irvine
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP