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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of California, Irvine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00969540
First received: August 31, 2009
Last updated: March 31, 2011
Last verified: March 2011
History of Changes
  Purpose

This is a research study because 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 mattress 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 is more useful in helping back pain and sleep quality.


Condition Intervention
Back Pain
Insomnia
 Device: specific mattress cover, placebo garment 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • OMPETFMC improves sleep quality in patients with lower back pain as measured by Clinical Global Impression (CGI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: June 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo mattress cover use
Subjects will be offered in this crossover double blind designed trial either the active or the placebo garment mattress cover. 14 day actigraphy with use of the provided study material is performed followed by the crossover offering of the appropriate garment for the next 14 days.
 Device: specific mattress cover, placebo garment mattress cover
Subjects will be offered in this crossover double blind designed trial either the active or the placebo garment mattress cover. 14 day actigraphy with use of the provided study material is performed followed by the crossover offering of the appropriate garment for the next 14 days.
Active Comparator: mattress cover
Subjects will be offered in this crossover double blind designed trial either the active or the placebo garment mattress cover. 14 day actigraphy with use of the provided study material is performed followed by the crossover offering of the appropriate garment for the next 14 days.
 Device: specific mattress cover, placebo garment mattress cover
Subjects will be offered in this crossover double blind designed trial either the active or the placebo garment mattress cover. 14 day actigraphy with use of the provided study material is performed followed by the crossover offering of the appropriate garment for the next 14 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
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 PM and 12 AM
  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 PM 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969540

Contacts
Contact: Annabel K Wang, MD 714-456-2332 akwang@uci.edu
Contact: Veronica Martin 714 456-7760 vero@uci.edu

Locations
United States, California
UC Irvine-MDA ALS and Neuromuscular Center Recruiting
Orange, California, United States, 92868
Contact: Veronica Martin     714-456-7760     vero@uci.edu    
Principal Investigator: Annabel Wang, MD            
Sub-Investigator: Tahseen Mozaffar, MD,FAAN            
Sub-Investigator: Marcel Hungs, MD,Ph.D            
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Annabel K Wang, MD UC Irvine
  More Information

No publications provided

Responsible Party: Annabel Wang, MD,, UC Irvine
ClinicalTrials.gov Identifier: NCT00969540     History of Changes
Other Study ID Numbers: mattress1
Study First Received: August 31, 2009
Last Updated: March 31, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013