Trial Outcomes & Findings for Trial on the Effect of Optically Modified Fiber Mattress Covers on Sleep Disturbances in Patients With Chronic Back Pain (NCT NCT00969540)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

14 days

Results posted on

2014-12-03

Participant Flow

Recruitment was by advertisement.

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.

Participant milestones

Participant milestones
Measure	Placebo Mattress Cover First, Then Active Mattress Cover Subjects were randomly assigned in this crossover double blind designed trial to the placebo mattress cover or active mattress cover for 14 days.	Active Mattress Cover First, Then Placebo Mattress Cover Subjects were randomly assigned in this crossover double blind designed trial to the active mattress cover or placebo mattress cover for 14 days.
Overall Study STARTED	4	4
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Mattress Cover First, Then Active Mattress Cover Subjects were randomly assigned in this crossover double blind designed trial to the placebo mattress cover or active mattress cover for 14 days.	Active Mattress Cover First, Then Placebo Mattress Cover Subjects were randomly assigned in this crossover double blind designed trial to the active mattress cover or placebo mattress cover for 14 days.
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Mattress Cover First, Then Active Mattress Cover n=3 Participants 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.	Active Mattress Cover First, Then Placebo Mattress Cover n=3 Participants 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 n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	46 years STANDARD_DEVIATION 13 • n=5 Participants	48 years STANDARD_DEVIATION 7 • n=7 Participants	47 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Population: The sponsor determined the size of the study.

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).