Brief Summary

Sleep disorders affect 40% of the adult population each year and are often associated with morbidity and mortality (Kripke et al., 2002; F.-Z. Low et al., 2017). Sleep quality plays a vital role in the overall quality of our lives. Therefore, a good sleep helps to create a quality life rhythm. A quality sleep reduces fatigue and increases physical regeneration (Khaleghipour et al., 2015). Poor sleep quality is due to various environmental factors such as temperature, light, noise and bed quality (Lei et al., 2009). It has been reported that 7% of sleep problems are caused by inappropriate mattresses that affect the load on the spine during sleep (F. Z. Low et al., 2017). Body contact pressure is a measure of the distribution of body weight across the body surface in contact with the mattress. A well-designed mattress usually has the ability to minimize high pressure points applied to the body. However, if the bed is not suitable for the person, pressure sores may develop in the body parts where pressure is intense (Cullum et al., 2004). The areas most affected by high pressure are usually the hips, shoulders and back, which can affect sleep quality and result in drowsiness or body stiffness throughout the day (Jacobson et al., 2002). A recent study by Bae and Ko compared the bed positions of hospital beds and found that a head-to-foot angle of 30° is the best position to reduce the likelihood of decubitus ulcers occurring in patients in high-pressure risk areas (Bae \& Ko, 2013). In the light of previous studies, it has been observed that there is no study comparing many bed types designed using different materials for individual-specific postures. Biomechanical comparison of these bedding materials in individuals with different posture types and sleeping in different sleeping positions will allow us to provide new insights into their pressure distribution abilities. The aim of this study is to measure the effect of mattresses made of different mattress materials on body contact pressure profiles in individuals with different postures in various sleeping positions. It will be evaluated using maximum body pressure and pressure distribution as outcome measures.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

210

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Oct 2022

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.7 years study duration

First Submitted

Initial submission to the registry

August 2, 2022

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed

2 months until next milestone

Study Start

First participant enrolled

October 15, 2022

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed

Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

1.5 years

First QC Date

August 2, 2022

Last Update Submit

August 2, 2022

Conditions

Pressure Ulcer Sleep Disorder Spine Degeneration Body Structure, Altered From Its Original Anatomical Structure

Outcome Measures

Primary Outcomes (1)

Measurement of Total Body Pressure
A pressure mat sensor (Pressure Mapping Sensor 5400N, Tekscan, Boston, MA) will first be calibrated on different beds using constant weights and then used to capture body contact pressure profiles in a video format for 6 minutes per stop at a sampling rate. 4 Hz Collected data will be edited in Matlab (MathWorks, Natick, MA) format for later recording. The posture screen analysis system will be used to determine the posture type of individuals.
40 minutes