UMIN-CTR Clinical Trial

Basic information
Public title	A study to investigate the effects of personal air conditioner on attenuating worker fatigue
Acronym	A study to investigate the effects of personal air conditioner on attenuating worker fatigue
Scientific Title	A study to investigate the effects of personal air conditioner on attenuating worker fatigue
Scientific Title:Acronym	A study to investigate the effects of personal air conditioner on attenuating worker fatigue
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of office environments on worker fatigue
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	work performance evaluation
Key secondary outcomes	VAS, autonomic nervous function evaluation, urinalysis

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	With personal air conditioner->Interval period (one week)->Without personal air conditioner
Interventions/Control_2	Without personal air conditioner->Interval period (one week)->With personal air conditioner
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1)Males and Females whose age of 20 years or more and less than 65 years 2)Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntary participate in the study and being able to personally sign a written informed consent
Key exclusion criteria	1)Subjects with serious renal, hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2)Subjects having the chronic fatigue syndrome (CFS), or subjects deemed to have severe fatigue like idiopathic chronic fatigue by the investigator 3)Subjects who are sensitive to cold 4)Subjects who mind the flow of air conditioner 5)Subjects who have claustrophobia 6)Subjects who receive regularly treatment for fatigue recovery (aromatherapy, reflexology, massage, etc.) or will receive it during study period 7)Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for recovery from fatigue or nutrient replenishment in case of physical fatigue 8)Subjects who take regularly Foods with Function Claims labeled the effect of attenuating fatigue sensation 9)Subjects who have the event which is much different from daily life during study period (house-moving, examination, etc.) 10)Subjects who are pregnant or lactating, or intending to become pregnant during the study 11)Subjects who are currently taking part in another clinical study 12)Subjects deemed unsuitable by the investigator
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Kosuke Middle name Last name Kondo
Organization	Shimizu Corporation
Division name	Institute of Technology
Zip code	135-8530
Address	3-4-17, Etchujima Koto-ku, Tokyo
TEL	03-3820-5504
Email	k-kondo@shimz.co.jp

Public contact
Name of contact person	1st name Tomohiro Middle name Last name Sugino
Organization	Soiken Inc.
Division name	R&D Division
Zip code	560-0082
Address	Senri Life Science Center 13F, 1-4-2, Shinsenre-higashimachi, Toyonaka-shi, Osaka
TEL	06-6871-8888
Homepage URL
Email	sugino@soiken.com

Sponsor
Institute	Soiken Inc.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB of Fukuda Clinic
Address	Shin-Osaka brick building 2F, 1-6- 1 Miyahara, Yodogawa-ku, Osaka-shi, Osaka
Tel	06-6398-0203
Email	fukudaclinicIRB@gmail.com

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	2022 Year 09 Month 03 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	18
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 05 Month 15 Day
Date of IRB	2021 Year 05 Month 15 Day
Anticipated trial start date	2021 Year 08 Month 18 Day
Last follow-up date	2021 Year 09 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 02 Month 28 Day
Last modified on	2022 Year 02 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053653