Adults 18 to 89, any sex, with Healthy Volunteer or Pressure Distribution. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Peak Sacral PressurePrimary· minutes 1-3 and minutes 6-8
Peak sacral pressure is defined as the highest pressure within a 9-10 cm squared area under the coccyx. The area under coccyx was identified prior to each condition tested using the pressure mapping system. Presure was recorded continuously for 15 minutes. Because the mattresses tested were advertised as 'cycling' pressure, with the cycles set to 5 minutes, the average of minutes 1-3 and 6-8 were used for analysis. These periods represent different phases of the 'cycling' where sacral pressure would conceivably differ.
Bed A, Head of Bed 0 degrees Minutes 1-3
Group
Value
95% CI
Healthy Adult Volunteers
17.8
± 4.2
Bed B, Head of Bed 0 degrees Minutes 1-3
Group
Value
95% CI
Healthy Adult Volunteers
21.0
± 4.5
Bed A, Head of Bed 0 degrees Minutes 6-8
Group
Value
95% CI
Healthy Adult Volunteers
17.1
± 4.9
Bed B, Head of Bed 0 degrees Minutes 6-8
Group
Value
95% CI
Healthy Adult Volunteers
21.6
± 4.6
Bed A, Head of Bed 30 degrees Minutes 1-3
Group
Value
95% CI
Healthy Adult Volunteers
17.3
± 6.0
Bed B, Head of Bed 30 degrees Minutes 1-3
Group
Value
95% CI
Healthy Adult Volunteers
24.9
± 8.7
Bed A, Head of Bed 30 degrees Minutes 6-8
Group
Value
95% CI
Healthy Adult Volunteers
16.9
± 5.2
Bed B, Head of Bed 30 degrees Minutes 6-8
Group
Value
95% CI
Healthy Adult Volunteers
25.7
± 8.6
Sponsor's own description
The purpose of the research study is to investigate the peak sacral interface pressures of two separate hospital bed systems in the supine and 30 degrees head-of-bed elevation position.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Alabama at Birmingham
Last refreshed: 20 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06661954.