UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061177 |
|---|---|
| Receipt number | R000070009 |
| Scientific Title | Sleep duration, oral functional impairment, and systemic inflammation: evidence from mediation analysis in a population-based study |
| Date of disclosure of the study information | 2026/04/08 |
| Last modified on | 2026/04/07 08:19:21 |
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Basic information
Public title
Relationship between Chewing difficulties and sleep duration
Acronym
Relationship between Chewing difficulties and sleep duration
Scientific Title
Sleep duration, oral functional impairment, and systemic inflammation: evidence from mediation analysis in a population-based study
Scientific Title:Acronym
Sleep duration, oral functional impairment, and systemic inflammation: evidence from mediation analysis in a population-based study
Region
| Japan |
Condition
Condition
This cross-sectional study included 8,252 Japanese adults undergoing health checkups.
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to examine the association between sleep duration and masticatory difficulties and to explore whether monocyte-related systemic inflammation is involved in this relationship.
Basic objectives2
Others
Basic objectives -Others
We aimed to examine the association between sleep duration and masticatory difficulties and to explore whether monocyte-related systemic inflammation is involved in this relationship.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between sleep duration and masticatory difficulties, and to explore whether monocyte-related systemic inflammation is involved in this relationship.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
This cross-sectional study was conducted using data from Japanese adults who underwent annual health checkups at the Health Planning Center of Nihon University Hospital between April 2024 and March 2025.
Key exclusion criteria
Declined consent
Missing data on sleep duration
Missing data on leukocyte subclasses
Missing data on masticatory status
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | SHIGEMASA |
| Middle name | |
| Last name | TANI |
Organization
Nihon University Hospital
Division name
Health Planning Center
Zip code
101-8309
Address
Kanda, Chiyodaku, 8309, Tokyo
TEL
09080537841
tani.shigemasa@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigemasa |
| Middle name | |
| Last name | Tani |
Organization
Nihon University Hospital
Division name
Health Planning Center
Zip code
342-0038
Address
Kanda, Chiyodaku, Tokyo
TEL
09080537841
Homepage URL
tani.shigemasa@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Hospital
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Hospital
Address
1-6 Kandasurugadai, chiyodaku
Tel
09080537841
tani.shigemasa@nihon-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
東京都
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 08 | 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
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
Preinitiation
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2026 | Year | 04 | Month | 07 | Day |
Last modified on
| 2026 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070009
