UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059108 |
|---|---|
| Receipt number | R000067615 |
| Scientific Title | A Study on a Method for Longitudinal Monitoring of Sleep Position in the Prone Position in Healthy Individuals |
| Date of disclosure of the study information | 2025/09/17 |
| Last modified on | 2025/09/17 13:22:45 |
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Basic information
Public title
A Study on a Method for Longitudinal Monitoring of Sleep Position in the Prone Position in Healthy Individuals
Acronym
A Study on a Method for Longitudinal Monitoring of Sleep Position in the Prone Position in Healthy Individuals
Scientific Title
A Study on a Method for Longitudinal Monitoring of Sleep Position in the Prone Position in Healthy Individuals
Scientific Title:Acronym
A Study on a Method for Longitudinal Monitoring of Sleep Position in the Prone Position in Healthy Individuals
Region
| Japan |
Condition
Condition
Healthy Individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate a method for longitudinal monitoring of the prone sleeping position in healthy individuals.
Basic objectives2
Others
Basic objectives -Others
Verification of the reliability and validity of measuring instruments
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Up-down and left-right direction of the face
Key secondary outcomes
Up-down and left-right direction of the body axis
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy individuals who provided informed consent for the study
Key exclusion criteria
Sleep disorder, lower back pain, eye disease, currently taking medication that affects sleep
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Tomoe |
| Middle name | |
| Last name | Yokono |
Organization
Niigata University Graduate School of Health Sciences
Division name
Department of Nursing
Zip code
951-8518
Address
2-746 Asahimachi-dori, Chuo-ku, Niigata, 951-8518, Japan
TEL
0252270940
tyokono@clg.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoe |
| Middle name | |
| Last name | Yokono |
Organization
Niigata University Graduate School of Health Sciences
Division name
Department of Nursing
Zip code
951-8518
Address
2-746 Asahimachi-dori, Chuo-ku, Niigata, 951-8518, Japan
TEL
0252270940
Homepage URL
tyokono@clg.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Tomoe Yokono
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Niigata University
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata, Japan
Tel
025-227-2625
ethics@adm.niigata-u.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
| 2025 | Year | 09 | Month | 17 | 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
5
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 28 | Day |
Other
Other related information
Nothing
Management information
Registered date
| 2025 | Year | 09 | Month | 17 | Day |
Last modified on
| 2025 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067615
