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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Back Pain
Insomnia
Interventions Device: Active Mattress Cover
Device: Placebo Mattress Cover
Enrollment 8
Recruitment Details Recruitment was by advertisement.
Pre-assignment Details A total of 8 participants were entered into this crossover study. The total duration of the study was approximately 49 days, including 14 days of screening and 14 days of the first intervention, 7 days of washout, and 14 days of the second intervention.
Arm/Group Title Placebo Mattress Cover First, Then Active Mattress Cover Active Mattress Cover First, Then Placebo Mattress Cover
Hide Arm/Group Description Subjects were randomly assigned in this crossover double blind designed trial to the placebo mattress cover or active mattress cover for 14 days. Subjects were randomly assigned in this crossover double blind designed trial to the active mattress cover or placebo mattress cover for 14 days.
Period Title: Overall Study
Started 4 4
Completed 3 3
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             1
Arm/Group Title Placebo Mattress Cover First, Then Active Mattress Cover Active Mattress Cover First, Then Placebo Mattress Cover Total
Hide Arm/Group Description Subjects in this crossover double blind designed trial will be randomized into the placebo mattress cover group for 14 days. After a 7 day washout, they will be entered into the active mattress cover group for 14 days. Subjects in this crossover double blind designed trial will be randomized into the active mattress cover group for 14 days. After a 7 day washout, they will be entered into the placebo mattress cover group for 14 days. Total of all reporting groups
Overall Number of Baseline Participants 3 3 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
3
 100.0%
6
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 6 participants
46  (13) 48  (7) 47  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
Female
3
 100.0%
3
 100.0%
6
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 6 participants
3 3 6
1.Primary Outcome
Title Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI).
Hide Description

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).

Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
The sponsor determined the size of the study.
Arm/Group Title Mean CGI Pain Scores With Placebo Mattress Cover. Mean CGI Pain Scores With Active Mattress Cover. Mean CGI Sleep Scores With Placebo Mattress Cover. Mean CGI Sleep Scores With Active Mattress Cover.
Hide Arm/Group Description:
Mean Clinical Global Impression pain scores with placebo mattress cover.
Mean Clinical Global Impression pain scores with active mattress cover.
Mean Clinical Global Impression sleep scores with placebo mattress cover.
Mean Clinical Global Impression sleep scores with active mattress cover.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
2.Secondary Outcome
Title Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain.
Hide Description Secondary outcome: Nighttime wake-time after sleep onset with placebo mattress cover compared to active mattress cover.
Time Frame Assessed daily for 14 days per intervention.
Hide Outcome Measure Data
Hide Analysis Population Description
The sponsor determined the number of participants.
Arm/Group Title Nighttime Wake Time With Placebo Mattress Cover Nighttime Wake Time With Active Mattress Cover
Hide Arm/Group Description:
Nighttime wake time after sleep onset with placebo mattress cover.
Nighttime wake time after sleep onset with active mattress cover.
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: Minutes
Subject 1 53.38  (26.70) 71.31  (28.42)
Subject 2 59.15  (19.72) 107.38  (50.76)
Subject 3 113.83  (34.37) 128.38  (77.08)
Subject 4 50.23  (35.30) 76.09  (37.27)
Subject 5 44.91  (50.58) 49.92  (38.70)
Subject 6 71.75  (25.11) 80.58  (27.49)
3.Secondary Outcome
Title Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain.
Hide Description Secondary outcome: Total sleep time with placebo mattress cover compared to active mattress cover.
Time Frame Assessed daily for 14 days per intervention.
Hide Outcome Measure Data
Hide Analysis Population Description
The sponsor determined the number of participants.
Arm/Group Title Total Sleep With Placebo Mattress Cover Total Sleep With Active Mattress Cover
Hide Arm/Group Description:
Total sleep with placebo mattress cover (minutes).
Total sleep with active mattress cover (minutes).
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: Minutes
Subject 1 433.15  (110.80) 435.92  (75.93)
Subject 2 406.54  (46.23) 384.00  (113.18)
Subject 3 447.83  (190.13) 435.46  (103.15)
Subject 4 401.54  (61.69) 400.73  (45.71)
Subject 5 476.45  (87.86) 451.85  (95.54)
Subject 6 394.67  (94.64) 341.75  (71.75)
4.Secondary Outcome
Title Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain.
Hide Description Secondary outcome: Number of nocturnal awakenings with placebo mattress cover compared to active mattress cover.
Time Frame Assessed daily for 14 days per intervention.
Hide Outcome Measure Data
Hide Analysis Population Description
The sponsor determined the number of participants.
Arm/Group Title Nocturnal Awakenings With Placebo Mattress Cover Nocturnal Awakenings With Active Mattress Cover
Hide Arm/Group Description:
Number of nocturnal awakenings with placebo mattress cover.
Number of nocturnal awakenings with active mattress cover.
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: Awakenings
Subject 1 19.85  (10.53) 23.46  (8.36)
Subject 2 10.62  (2.40) 12.31  (4.13)
Subject 3 19.08  (5.32) 22.23  (11.06)
Subject 4 20.38  (12.59) 26.27  (9.88)
Subject 5 10.73  (10.14) 10.54  (7.49)
Subject 6 17.17  (4.84) 18.25  (6.33)
5.Secondary Outcome
Title Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain.
Hide Description Secondary outcome: Sleep efficiency in placebo mattress cover compared to active mattress cover.
Time Frame Assessed daily for 14 days per intervention.
Hide Outcome Measure Data
Hide Analysis Population Description
The sponsor determined the number of participants.
Arm/Group Title Sleep Efficiency With Placebo Mattress Cover Sleep Efficiency With Active Mattress Cover
Hide Arm/Group Description:
Sleep efficiency with placebo mattress cover.
Sleep efficiency with active mattress cover.
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: Percentage of time asleep
Subject 1 88.17  (5.51) 85.65  (5.62)
Subject 2 87.28  (2.76) 76.72  (14.18)
Subject 3 79.35  (9.30) 75.95  (14.84)
Subject 4 88.37  (7.64) 84.00  (7.68)
Subject 5 90.85  (10.28) 89.58  (8.28)
Subject 6 83.79  (2.53) 79.67  (6.02)
6.Secondary Outcome
Title Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain.
Hide Description Secondary outcome: Sleep latency in placebo mattress cover compared to active mattress cover.
Time Frame Assessed daily for 14 days per intervention.
Hide Outcome Measure Data
Hide Analysis Population Description
The sponsor determined the number of participants.
Arm/Group Title Sleep Latency With Placebo Mattress Cover Sleep Latency With Active Mattress Cover
Hide Arm/Group Description:
Sleep latency with placebo mattress cover (minutes).
Sleep latency with active mattress cover (minutes).
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: Minutes
Subject 1 2.92  (5.06) 1.46  (2.50)
Subject 2 1.15  (3.36) 0  (0)
Subject 3 9.75  (18.86) 7.54  (18.33)
Subject 4 2.69  (9.71) .27  (0.90)
Subject 5 0.91  (2.43) 0.15  (0.55)
Subject 6 4.83  (7.03) 5.17  (10.66)
Time Frame 1 year 2 months (April 2010-June 2011)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Mattress Cover Active Mattress Cover
Hide Arm/Group Description Subjects will be randomly assigned in this crossover double blind designed trial to the placebo mattress cover for 14 days, followed by the active mattress cover for 14 days after a 7 day wash out period. Subjects will be randomly assigned in this crossover double blind designed trial to the active mattress cover for 14 days, followed by the placebo mattress cover for 14 days after a 7 day wash out period.
All-Cause Mortality
Placebo Mattress Cover Active Mattress Cover
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Mattress Cover Active Mattress Cover
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Mattress Cover Active Mattress Cover
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Seth Casden
Organization: Hologenix, LLC
Phone: 310-600-3673
EMail: seth.casden@celiant.com
Layout table for additonal information
Responsible Party: Annabel Kim Wang, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00969540    
Other Study ID Numbers: mattress1
First Submitted: August 31, 2009
First Posted: September 1, 2009
Results First Submitted: June 29, 2012
Results First Posted: December 3, 2014
Last Update Posted: December 3, 2014