UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045165 |
|---|---|
| Receipt number | R000051517 |
| Scientific Title | Effect of cardboard bed on the body pressure distribution and the sleep quality. |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2024/06/25 11:20:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of cardboard bed on the body pressure distribution and the sleep quality.
Acronym
Effect of cardboard bed on the body pressure distribution and the sleep quality.
Scientific Title
Effect of cardboard bed on the body pressure distribution and the sleep quality.
Scientific Title:Acronym
Effect of cardboard bed on the body pressure distribution and the sleep quality.
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of a cardboard bed on the body pressure distribution and sleep quality.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the body contact pressure
the body surface contour area
objective sleep related index (sleep EEG)
Key secondary outcomes
subjective sleep related index
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Sleep with the cardboard bed for one night
Interventions/Control_2
Sleep with the camping cot for one night
Interventions/Control_3
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. People who can give written informed consent.
2. People who can read and fill out explanatory documents, consent forms, and survey forms written in Japanese.
3. People who can write consent to participate in the research.
4. People aged between 18 and 50 years.
5. Healthy people without medications for sleeping disorders.
Key exclusion criteria
1. People with irregular sleep-wake rhythm
2. People who are taking medicines for psychiatric or sleep disorders.
3. Night worker or shift worker.
4. People who plan to travel to areas with a time difference of 3 hours or more.
5. Pregnancy or breastfeeding women.
6. People who have a disease that may change suddenly.
7. People with physical symptoms which interfere with sleep.
8. The score of Epworth Sleepiness Scale >= 11
9. Current smoker.
10. People who are judged not suitable to participate in this trial by investigators.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | SEIJI |
| Middle name | |
| Last name | HAMANISHI |
Organization
Kansai University of Social Welfare
Division name
Faculty of Nursing
Zip code
678-0255
Address
380-3 Shinden, Ako, Hyogo
TEL
0791-46-2545
sj.eyes76@gmail.com
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Hamanishi |
Organization
Kansai University of Social Welfare
Division name
Faculty of Nursing
Zip code
678-0255
Address
380-3 Shinden, Ako, Hyogo
TEL
0791-46-2545
Homepage URL
hamanishi@kusw.ac.jp
Sponsor or person
Institute
Kansai University of Social Welfare
Institute
Department
Personal name
Seiji hamanishi
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical review board of Kansai University of Social Welfare
Address
380-3 Shinden, Ako, Hyogo
Tel
0791-46-2545
kusw-kango@kusw.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 01 | 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
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 11 | Month | 10 | Day |
Date analysis concluded
| 2023 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 16 | Day |
Last modified on
| 2024 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051517
