Healthy VolunteerNCT06661954

Comparison of Sacral Interface Pressure in Healthy Volunteers on Two Dynamic Pressure-Prevention Support Surfaces

A study testing Bed A - Head of Bed 0 degrees, Bed B - Head of Bed 0 degrees and Bed A - Head of bed at 30 degrees in people with Healthy Volunteer and Pressure Distribution, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 89 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer, Pressure Distribution
What is being tested?: Bed A - Head of Bed 0 degrees, Bed B - Head of Bed 0 degrees and Bed A - Head of bed at 30 degrees
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 11 Oct 2024to 23 Oct 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 89 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

non-disabled
can walk \& stand independently
can visit UAB SIM Lab once for 45 to 60 minutes

Who cannot join

-skin breakdown or compromising skin conditions

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Alabama
Birmingham, Alabama, 35294

Other trials in United States

About this study

Official title: Sacral Interface Pressure Mapping of Hospital Bed Systems

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.

Conditions: Healthy Volunteer, Pressure Distribution
Being tested: Bed A - Head of Bed 0 degrees, Bed B - Head of Bed 0 degrees, Bed A - Head of bed at 30 degrees, Bed B - head of bed at 30 degrees
Keywords: Pressure Injury, Pressure Mapping
Medical subject headings: Pressure Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bed A - Head of Bed 0 degreesDevice
Low air loss mattress in supine position
Bed B - Head of Bed 0 degreesDevice
Standard hospital mattress in supine position
Bed A - Head of bed at 30 degreesDevice
Low air loss mattress with head of bed at 30 degrees
Bed B - head of bed at 30 degreesDevice
Standard hospital mattress with head of bed at 30 degrees

Study groups in NCT06661954
Study group	Role	What they receive
Healthy Adult Volunteers	Experimental	One Arm. Repeated measures. All participants are assessed in each of the four bed-position configurations. Bed-position assessment sequence is randomized for each participant. Receives: Device: Bed A - Head of Bed 0 degrees; Device: Bed B - Head of Bed 0 degrees; Device: Bed A - Head of bed at 30 degrees; Device: Bed B - head of bed at 30 degrees

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak Sacral Pressure
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.
Measured: minutes 1-3 and minutes 6-8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Oct 202423 Oct 2024

First posted28 Oct 2024
Study start11 Oct 2024
Primary completion23 Oct 2024
Study completion23 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteerStudies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06661954
Sponsor's protocol ID: IRB-300012406
Status last verified: Nov 2025
First submitted: 24 Oct 2024
Last updated: 20 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: A deidentified data set will be shared upon request contingent on execution of a data sharing/use agreement between the PI's institution and the individual/institution/organization requesting the data.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sacral Interface Pressure Mapping of Hospital Bed Systems
ClinicalTrials.gov ID: NCT06661954
Acronym / sponsor ID: IRB-300012406
Conditions: Healthy Volunteer, Pressure Distribution
Keywords: Pressure Injury, Pressure Mapping
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Study start: 11 Oct 2024 (actual)
Primary completion: 23 Oct 2024 (actual)
Study completion: 23 Oct 2024 (actual)
First posted: 28 Oct 2024 (actual)
Results: Posted 20 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Healthy Adult Volunteers	Experimental	Device: Bed A - Head of Bed 0 degrees, Device: Bed B - Head of Bed 0 degrees, Device: Bed A - Head of bed at 30 degrees, Device: Bed B - head of bed at 30 degreesOne Arm. Repeated measures. All participants are assessed in each of the four bed-position configurations. Bed-position assessment sequence is randomized for each participant.

Who may qualify

Ages: 18 to 89 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

non-disabled
can walk \& stand independently
can visit UAB SIM Lab once for 45 to 60 minutes

Key exclusion criteria (1 listed)

-skin breakdown or compromising skin conditions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bed A - Head of Bed 0 degreesLow air loss mattress in supine position	Device	Healthy Adult Volunteers
Bed B - Head of Bed 0 degreesStandard hospital mattress in supine position	Device	Healthy Adult Volunteers
Bed A - Head of bed at 30 degreesLow air loss mattress with head of bed at 30 degrees	Device	Healthy Adult Volunteers
Bed B - head of bed at 30 degreesStandard hospital mattress with head of bed at 30 degrees	Device	Healthy Adult Volunteers

Primary outcome

Peak Sacral Pressure
Time frame: 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.

Results and safety

Results posted to the registry on 20 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Adult Volunteers	18	18

Primary outcome: Peak Sacral Pressure

Time frame: minutes 1-3 and minutes 6-8. Mean (Standard Deviation). Unit: mm hg

Measure	Healthy Adult Volunteers n = 16
Bed A, Head of Bed 0 degrees Minutes 1-3	17.8 (4.2)
Bed B, Head of Bed 0 degrees Minutes 1-3	21.0 (4.5)
Bed A, Head of Bed 0 degrees Minutes 6-8	17.1 (4.9)
Bed B, Head of Bed 0 degrees Minutes 6-8	21.6 (4.6)
Bed A, Head of Bed 30 degrees Minutes 1-3	17.3 (6.0)
Bed B, Head of Bed 30 degrees Minutes 1-3	24.9 (8.7)
Bed A, Head of Bed 30 degrees Minutes 6-8	16.9 (5.2)
Bed B, Head of Bed 30 degrees Minutes 6-8	25.7 (8.6)

Healthy Adult Volunteers: p <0.05, t-test, 2 sided

Population analysed: 18 participants completed the data collection protocol. 16 participants were included in the analysis. 2 participants were excluded from all analyses after inspection of their data suggested the position of the coccyx had been misidentified.

Adverse events

Time frame: From signing of the informed consent form until getting off the final Bed-Position that was tested. All testing occurred during one visit to the laboratory lasting up to 90 minutes.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Adult Volunteers	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Limitations and caveats (from the sponsor): The pressure mapping system used to record peak pressures was a clinical system. This system does not allow for export of the continuous recording. One minute averages had to be computed on the clinical system and then manually transcribed into excel. Participants self-palpated the location of the ischial tuberosities and coccyx. These regions were then labelled on the clinical pressure mapping system. These methodological limitations are assumed to decrease precision.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. A deidentified data set will be shared upon request contingent on execution of a data sharing/use agreement between the PI's institution and the individual/institution/organization requesting the data.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rachel Cowan, MD principal investigator

University of Alabama at Birmingham

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Sacral Pressure (time frame: minutes 1-3 and minutes 6-8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06661954.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.