UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051098 |
|---|---|
| Receipt number | R000058271 |
| Scientific Title | The effect of sleep quality on skeletal muscle mass in healthy adults |
| Date of disclosure of the study information | 2023/05/22 |
| Last modified on | 2023/06/05 10:00:53 |
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Basic information
Public title
The effect of sleep quality on skeletal muscle mass in healthy adults
Acronym
The effect of sleep quality on skeletal muscle mass in healthy adults
Scientific Title
The effect of sleep quality on skeletal muscle mass in healthy adults
Scientific Title:Acronym
The effect of sleep quality on skeletal muscle mass in healthy adults
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between non-REM sleep duration and skeletal muscle mass in healthy adults
Basic objectives2
Others
Basic objectives -Others
To investigate the Correlation between Non-REM Sleep Duration and Skeletal Muscle Mass in Healthy Adults
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
skeletal muscle mass
Key secondary outcomes
grip strength
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy adults aged 18 or above but below 40 years old
Key exclusion criteria
1.Individuals diagnosed with sleep disorders.
2.Individuals regularly taking medication or supplements that affect sleep.
3.Any other individuals deemed inappropriate as research participants by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Sawada |
Organization
Health Sciences University of Hokkaido
Division name
School of Rehabilitation Sciences
Zip code
061-0293
Address
1757, Kanazawa, Tobestu, Hokkaido, Japan
TEL
0133-23-1219
as-51@hoku-iryo-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Sawada |
Organization
Health Sciences University of Hokkaido
Division name
School of Rehabilitation Sciences
Zip code
061-0293
Address
1757, Kanazawa, Tobestu, Hokkaido, Japan
TEL
0133-23-1219
Homepage URL
as-51@hoku-iryo-u.ac.jp
Sponsor or person
Institute
Health Sciences University of Hokkaido
Institute
Department
Personal name
Atsushi Sawada
Funding Source
Organization
Health Sciences University of Hokkaido
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Health Sciences University of Hokkaido
Address
1757, Kanazawa, Tobestu, Hokkaido, Japan
Tel
0133-23-1211
kyo-reha@hoku-iryo-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
| 2023 | Year | 05 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigation of the Correlation between Non-REM Sleep and Skeletal Muscle Mass, as well as the Correlation between Non-REM Sleep and Grip Strength
Management information
Registered date
| 2023 | Year | 05 | Month | 18 | Day |
Last modified on
| 2023 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058271
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
