Back PainNCT00969540

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

A study testing Active Mattress Cover in people with Back Pain and Insomnia, run by University of California, Irvine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Back Pain, Insomnia
What is being tested?: Active Mattress Cover
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 8 participants
Where: 1 siteUnited States
Study dates: Jun 2009to Jul 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

UC Irvine-MDA ALS and Neuromuscular Center
Orange, California, 92868

Other trials in United States

About this study

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

Read the 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.

Conditions: Back Pain, Insomnia
Being tested: Active Mattress Cover, Placebo Mattress Cover
Keywords: Back Pain, Sleep
Medical subject headings: Back Pain, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active Mattress CoverDevice
Active Mattress Cover
Placebo Mattress CoverDevice
Placebo Mattress Cover

Study groups in NCT00969540
Study group	Role	What they receive
Active Mattress Cover	Active comparator	Subjects in this arm will be given the placebo mattress cover followed active mattress cover . Receives: 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. Receives: Device: Placebo Mattress Cover

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 14 days

Secondary outcomes (5)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed daily for 14 days per intervention.
Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain.
Secondary outcome: Sleep latency in placebo mattress cover compared to active mattress cover.
Measured: Assessed daily for 14 days per intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Jul 2011

First posted1 Sep 2009 (estimated)
Study startJun 2009
Primary completionJul 2011
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Back PainStudies of the same condition, open and under way.
More trials run by University of California, IrvineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00969540
Sponsor's protocol ID: 2009-6927
Status last verified: Dec 2014
First submitted: 31 Aug 2009
Last updated: 27 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain

All Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00969540
Acronym / sponsor ID: 2009-6927
Conditions: Back Pain, Insomnia
Keywords: Back Pain, Sleep
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: University of California, IrvineUniversity, hospital or other
Study start: Jun 2009
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 1 Sep 2009 (estimated)
Results: Posted 3 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active Mattress Cover	Active comparator	Device: Active Mattress CoverSubjects in this arm will be given the placebo mattress cover followed active mattress cover .
Placebo Mattress Cover	Placebo comparator	Device: Placebo Mattress CoverSubjects in this arm will be given the active mattress cover followed by the placebo mattress cover.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Active Mattress CoverActive Mattress Cover	Device	Active Mattress Cover
Placebo Mattress CoverPlacebo Mattress Cover	Device	Placebo Mattress Cover

Primary outcome

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).

5 secondary outcomes

Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain.
Time frame: Assessed daily for 14 days per intervention.
Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain.
Time frame: Assessed daily for 14 days per intervention.
Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain.
Time frame: Assessed daily for 14 days per intervention.
Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain.
Time frame: Assessed daily for 14 days per intervention.
Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain.
Time frame: Assessed daily for 14 days per intervention.

Results and safety

Results posted to the registry on 3 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Mattress Cover First, Then Active Mattress Cover	4	3
Active Mattress Cover First, Then Placebo Mattress Cover	4	3

Primary outcome: 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. Mean (Standard Deviation). Unit: units on a scale

Measure	Mean CGI Pain Scores With Placebo Mattress Cover. n = 6	Mean CGI Pain Scores With Active Mattress Cover. n = 6	Mean CGI Sleep Scores With Placebo Mattress Cover. n = 6	Mean CGI Sleep Scores With Active Mattress Cover. n = 6
Subject 1	4.07 (1.27)	3.86 (1.10)	3.93 (1.27)	3.86 (1.10)
Subject 2	3.86 (0.53)	3.86 (0.66)	3.86 (0.77)	3.93 (0.62)
Subject 3	4.00 (0.00)	4.00 (0.00)	3.92 (0.29)	4.00 (0.00)
Subject 4	4.00 (0.00)	4.07 (0.27)	4.00 (0.00)	4.00 (0.00)
Subject 5	3.00 (0.00)	3.00 (0.00)	3.14 (0.53)	3.00 (0.00)
Subject 6	4.00 (0.00)	4.00 (0.00)	4.00 (0.00)	4.00 (0.00)

Population analysed: The sponsor determined the size of the study.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year 2 months (April 2010-June 2011). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Mattress Cover	0 of 3 (0%)	0 of 3 (0%)	Not reported
Active Mattress Cover	0 of 3 (0%)	0 of 3 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Back Pain

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Annabel K Wang, MD principal investigator

UC Irvine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Active Mattress Cover in people with Back Pain and Insomnia, run by University of California, Irvine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00969540.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.