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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Annabel Kim Wang, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00969540
First received: August 31, 2009
Last updated: December 2, 2014
Last verified: December 2014
  Purpose
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.

Condition Intervention
Back Pain
Insomnia
Device: Active Mattress Cover
Device: Placebo Mattress Cover

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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).



Secondary Outcome Measures:
  • Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain. [ Time Frame: Assessed daily for 14 days per intervention. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Secondary outcome: Sleep latency in placebo mattress cover compared to active mattress cover.


Enrollment: 8
Study Start Date: June 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Mattress Cover
Subjects in this arm will be given the placebo mattress cover followed active mattress cover .
Device: Active Mattress Cover
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.
Device: Placebo Mattress Cover
Placebo Mattress Cover

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969540

Locations
United States, California
UC Irvine-MDA ALS and Neuromuscular Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Annabel K Wang, MD UC Irvine
  More Information

Responsible Party: Annabel Kim Wang, Associate Clinical Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00969540     History of Changes
Other Study ID Numbers: mattress1 
Study First Received: August 31, 2009
Results First Received: June 29, 2012
Last Updated: December 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Back Pain
Sleep

Additional relevant MeSH terms:
Back Pain
Dyssomnias
Sleep Wake Disorders
Parasomnias
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on December 02, 2016