Adaptation of Mattresses Made With Different Materials to Personal Anthropometry Values and Body Postures

Sleep Disorder Clinical Trial

Official title:

Adaptation of Mattresses Made With Different Materials to Personal Anthropometry Values and Body Postures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05486039
• Other study ID #: 28-06-22/26
• Status: Not yet recruiting
• Start date: October 15, 2022
• Est. completion date: June 15, 2024

Study information

• Verified date: August 2022
• Source: Hacettepe University
• Contact: Ceyhun Türkmen, Ph.D.
• Phone: +905311017392
• Email: fztceyhunturkmen[@]karatekin.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: June 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Volunteer to participate in research

Exclusion Criteria:

• Having a history of back, shoulder or neck pain in the last 6 weeks

• Having a surgical operation in the last 8 weeks

Related Conditions & MeSH terms

• Pressure Ulcer
• Sleep Disorder
• Sleep Wake Disorders
• Spine Degeneration

Intervention

Behavioral:
• Changing behaviour
Changing the lying position and mattress system

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

References & Publications (5)

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. — View Citation

Cullum N, McInnes E, Bell-Syer SE, Legood R. Support surfaces for pressure ulcer prevention. Cochrane Database Syst Rev. 2004;(3):CD001735. Review. Update in: Cochrane Database Syst Rev. 2008;(4):CD001735. — View Citation

Jacobson BH, Gemmell HA, Hayes BM, Altena TS. Effectiveness of a selected bedding system on quality of sleep, low back pain, shoulder pain, and spine stiffness. J Manipulative Physiol Ther. 2002 Feb;25(2):88-92. — View Citation

Kripke DF, Garfinkel L, Wingard DL, Klauber MR, Marler MR. Mortality associated with sleep duration and insomnia. Arch Gen Psychiatry. 2002 Feb;59(2):131-6. — View Citation

Low FZ, Chua MC, Lim PY, Yeow CH. Effects of Mattress Material on Body Pressure Profiles in Different Sleeping Postures. J Chiropr Med. 2017 Mar;16(1):1-9. doi: 10.1016/j.jcm.2016.09.002. Epub 2016 Oct 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Pittsburg Health Quality Index	The Pittsburg Sleep Quality Scale will be used to obtain more detailed data on current sleep quality from individuals (Buysse et al., 1989).	40 minutes