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

NCT00969540 | Completed Results

• 1 other identifier: mattress1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain; Insomnia

Keywords

Back Pain; Sleep

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain.

  Assessed daily for 14 days per intervention.

• Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain.

  Assessed daily for 14 days per intervention.

• Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain.

  Assessed daily for 14 days per intervention.

• Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain.

  Assessed daily for 14 days per intervention.

• Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain.

  Assessed daily for 14 days per intervention.

Study Arms (2)

Active Mattress Cover

ACTIVE COMPARATOR

Subjects in this arm will be given the placebo mattress cover followed active mattress cover .

Device: Active Mattress Cover

Placebo Mattress Cover

PLACEBO COMPARATOR

Subjects in this arm will be given the active mattress cover followed by the placebo mattress cover.

Device: Placebo Mattress Cover

Interventions

Active Mattress Cover DEVICE

Active Mattress Cover

Active Mattress Cover

Placebo Mattress Cover DEVICE

Placebo Mattress Cover

Placebo Mattress Cover

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• You are eligible to participate in this study if you:
• have a clinical diagnosis of chronic lower back pain
• have pain measured on the Visual Analogue scale
• have sleep disturbances at night associated with chronic lower back pain
• are 18 years or older
• sign the written, informed consent form prior to the initiation of any study procedures
• have an habitual bedtime between 8 P.M. and 12 A.M.
• are on a stable pain management regime

You may not qualify if:

• You are not eligible to participate in this study if you:
• are unwilling or unable to comply with the protocol or scheduled appointments
• are unable to understand the language in which the approved informed consent is written
• have no pain measured on the Visual Analogue scale
• are unable to walk, wheel chair bound or confined to bed
• 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
• lack a mobile arm to which to attach an actigraphy.
• are currently participate or participated in another clinical study within the past 30 days
• 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
• use tobacco products or any other products during nightly awakenings that may interfere with the sleep wake cycle
• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

UC Irvine-MDA ALS and Neuromuscular Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Back Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Limitations and Caveats

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.

Results Point of Contact

• Title: Seth Casden
• Organization: Hologenix, LLC

seth.casden@celiant.com

310-600-3673

Study Officials

• Annabel K Wang, MD

  UC Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: August 31, 2009
• First Posted: September 1, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: December 3, 2014
• Results First Posted: December 3, 2014

Record last verified: 2014-12

Locations

US (1)