UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063099 |
|---|---|
| Receipt number | R000072233 |
| Scientific Title | Effects of different mattress toppers on body pressure distribution and RMSSD during supine rest: a randomized crossover study |
| Date of disclosure of the study information | 2026/09/29 |
| Last modified on | 2026/09/29 16:33:57 |
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Basic information
Public title
Effects of different mattress toppers on body pressure distribution and heart rate variability during supine rest
Acronym
Mattress Topper Study
Scientific Title
Effects of different mattress toppers on body pressure distribution and RMSSD during supine rest: a randomized crossover study
Scientific Title:Acronym
Mattress Topper Crossover Study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare body pressure distribution and the heart rate variability index RMSSD during supine rest under three different mattress topper conditions, and to examine within-participant associations between body pressure distribution and RMSSD.
Basic objectives2
Others
Basic objectives -Others
Evaluation of short-term physiological responses to different bedding conditions
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
RMSSD (root mean square of successive differences) calculated from R-R intervals recorded during the final 5 minutes of the 10-minute supine-rest period under each mattress topper condition.
Key secondary outcomes
Peak pressure (mmHg) and support area for the total body, head, chest, and buttocks regions measured during the final minute of the 10-minute supine-rest period under each mattress topper condition. Within-participant associations between these body pressure variables and RMSSD were also explored.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Standard condition: Participants rested supine with their eyes closed for 10 minutes in a darkened room on a mattress topper (nobirakuPro, Yumeron Kurokawa, Fukui, Japan) containing approximately 27 cylindrical urethane cushions. A 10-minute seated washout period in a bright room was provided between intervention conditions.
Interventions/Control_2
Firm condition: Participants rested supine with their eyes closed for 10 minutes in a darkened room on a mattress topper with the same cylindrical structure as the Standard condition but with material hardness increased by 40%. A 10-minute seated washout period in a bright room was provided between intervention conditions.
Interventions/Control_3
Conventional condition: Participants rested supine with their eyes closed for 10 minutes in a darkened room on a commercially available conventional mattress topper. A 10-minute seated washout period in a bright room was provided between intervention conditions.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 20 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy university students aged 18-20 years who provided written informed consent to participate in the study.
Key exclusion criteria
Participants with persistent pain, a history of sleep or psychiatric disorders, use of medications affecting autonomic function, or skin disorders preventing sensor attachment were excluded.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yoshitomo |
| Middle name | |
| Last name | Saiki |
Organization
Fukui Health Science University
Division name
Department of Rehabilitation, Faculty of Health Science
Zip code
9103190
Address
55-13-1 Egami, Fukui City, Fukui 910-3190, Japan
TEL
0776-59-2200
yoshitomosaiki@gmail.com
Public contact
Name of contact person
| 1st name | Yoshitomo |
| Middle name | |
| Last name | Saiki |
Organization
Fukui Health Science University
Division name
Department of Rehabilitation, Faculty of Health Science
Zip code
9103190
Address
55-13-1 Egami, Fukui City, Fukui 910-3190, Japan
TEL
0776-59-2200
Homepage URL
yoshitomosaiki@gmail.com
Sponsor or person
Institute
Fukui Health Science University
Institute
Department
Personal name
Yoshitomo saiki
Funding Source
Organization
Yumeron Kurokawa
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Nittazuka Medical and Welfare Center
Address
58-16-1 Egami, Fukui City, Fukui, Japan
Tel
0776-59-1300
yoshitomosaiki@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
福井医療大学（福井県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
16
Results
Sixteen healthy university students were analyzed. The Standard condition showed lower peak pressure and greater support area in the total body, chest, and buttocks regions than the Firm and Conventional conditions. RMSSD was higher under the Standard and Firm conditions than under the Conventional condition. In linear mixed-effects models, chest support area was positively associated with RMSSD, whereas head peak pressure was negatively associated with RMSSD.
Results date posted
| 2026 | Year | 09 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Sixteen participants were included (6 men and 10 women). Mean age was 19.6 +/- 0.6 years.
Participant flow
Sixteen participants were enrolled and randomized to an intervention sequence. All 16 participants completed all three mattress topper conditions. There were no dropouts or participants excluded from the analysis, and all 16 participants were included in the final analysis.
Adverse events
No adverse events were observed.
Outcome measures
The primary outcome was RMSSD calculated from R-R intervals recorded during the final 5 minutes of the 10-minute supine-rest period under each mattress topper condition. Secondary outcomes were peak pressure and support area for the total body, head, chest, and buttocks regions measured during the final minute of each condition. Within-participant associations between body pressure variables and RMSSD were also explored.
Plan to share IPD
There is no current plan to publicly share individual participant data.
IPD sharing Plan description
Individual participant data will not be made publicly available because of privacy and ethical considerations. De-identified data may be considered for sharing upon reasonable request, subject to ethical and institutional approval.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 11 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 27 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 29 | Day |
Last modified on
| 2026 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072233
