UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055533 |
|---|---|
| Receipt number | R000063458 |
| Scientific Title | A prospective observational study evaluating the implementation and short-term outcomes of a multi-component workplace sleep health program combining sleep education, GABA supplementation, and wearable monitoring among professional drivers in Japan |
| Date of disclosure of the study information | 2024/09/18 |
| Last modified on | 2026/06/25 09:46:26 |
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Basic information
Public title
Prospective Observational Study to Investigate the Utility of Nestle Health Science Sleep Program with Fitbit in professional drivers.
Acronym
Observational study for evaluating the effectiveness of NHS Sleep Program with Fitbit in professional drivers.
Scientific Title
A prospective observational study evaluating the implementation and short-term outcomes of a multi-component workplace sleep health program combining sleep education, GABA supplementation, and wearable monitoring among professional drivers in Japan
Scientific Title:Acronym
Prospective observational study of a multi-component workplace sleep health program among professional drivers
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Component workplace sleep health program consisting of sleep education, daily GABA supplementation at 700 mg/day, and wearable sleep monitoring among professional drivers, and to evaluate within-participant changes in sleep-related outcomes, stress responses, and work productivity indicators under routine occupational settings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Sleep Quality
SP
Fatigue at the start of work
Stress indicators
Fitbit sleep-related data
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Those who are engaged in truck driving
2.Those who have decided to participate in the sleep program of their own free will
3.Those who have fully understood the content of the research and have given their own free consent to participate in the research
Key exclusion criteria
Those who have been diagnosed with some kind of sleep disorder
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yukikazu |
| Middle name | |
| Last name | Kamada |
Organization
Nestle Japan Ltd
Division name
Nestle Health Science Company
Zip code
140-0002
Address
Tennouzu Ocean Square 20F, 2-2-20 Higashi-Shinagawa, Shinagawa-ku, Tokyo
TEL
070-2278-7597
Yukikazu.Kamada@jp.nestle.com
Public contact
Name of contact person
| 1st name | Yukikazu |
| Middle name | |
| Last name | Kamada |
Organization
Nestle Japan Ltd
Division name
Nestle Health Science Company
Zip code
140-0002
Address
Tennouzu Ocean Square 20F, 2-2-20 Higashi-Shinagawa, Shinagawa-ku, Tokyo
TEL
070-2278-7597
Homepage URL
Yukikazu.Kamada@jp.nestle.com
Sponsor or person
Institute
Nestle Health Science Company, Nestle Japan Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical review committee of RESM
Address
3-8-12 Shinyokohama, Kohoku-ku, Yokohama-shi, Kanagawa, Japan.
Tel
045-475-5155
https://www.resm.info/
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
| 2024 | Year | 09 | Month | 18 | 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
29
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
| 2024 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This update clarifies the program components that were included in the ethics-approved protocol and participant information materials from the outset. This study was not designed to estimate the causal effect of GABA supplementation or any individual program component, but to describe the implementation and within-participant changes associated with a multi-component workplace sleep health program in a prospective observational setting.
Management information
Registered date
| 2024 | Year | 09 | Month | 18 | Day |
Last modified on
| 2026 | 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=R000063458
