UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the effects of sauna bathing with the personal sauna "KUU" on body temperature, peripheral blood flow, skin condition, autonomic nerves and QOL
Acronym	Examination of the effects of sauna bathing with the personal sauna "KUU" on body temperature, peripheral blood flow, skin condition, autonomic nerves and QOL
Scientific Title	Examination of the effects of sauna bathing with the personal sauna "KUU" on body temperature, peripheral blood flow, skin condition, autonomic nerves and QOL
Scientific Title:Acronym	Examination of the effects of sauna bathing with the personal sauna "KUU" on body temperature, peripheral blood flow, skin condition, autonomic nerves and QOL
Region	Japan

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

Objectives
Narrative objectives1	This test is to examine the effects of sauna bathing on body temperature, peripheral blood flow, skin condition, autonomic nerves and QOL by using the test product (personal sauna "KUU").
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Indexes for effectiveness(Weight/body fat percentage/BMI(1), Salivary amylase(1), Sublingual thermometry(2), Blood flow measurement with TOKU Capillaro(3), Skin surface temperature measurement with thermography(4), Autonomic nerve function(1), Image analysis by VISIA(1), Skin moisture content(1), Japanese version of the UWIST Mood Checklist(5), St. Mary's Hospital Sleep Questionnaire(6) and Visual Analogue Scale(6).) (1) Before sauna bath and after 30 minutes of 2 sets of sauna bath. (2) Before sauna bath, during outside air bath (2 times), immediately after 2 sets of sauna baths, after 30 minutes of 2 sets of sauna bath. (3) Before sauna bath, immediately after 2 sets of sauna baths, after 30 minutes of 2 sets of sauna bath. (4) Before sauna bath and immediately after 2 sets of sauna baths. (5) Before sauna bath, after 30 minutes of 2 sets of sauna bath and when waking up the next day. (6) Before sauna bath and when waking up the next day.
Key secondary outcomes	*Safety [1] Blood pressure, pulsation. [2] Doctor's questions. [3] Adverse events: number of cases and expression rate of adverse events. (1)Before sauna bath and after 30 minutes of 2 sets of sauna bath. (2) After 30 minutes of 2 sets of sauna bath.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Other
Interventions/Control_1	Single use of test product (2 sets of 8 minutes sauna, 1 minute water bath, and 5 minutes outside air bath)
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	60 years-old >
Gender	Female
Key inclusion criteria	[1] Healthy Japanese females aged 20-59 years. [2] Individuals who are healthy and have no chronic physical disease including skin disease. [3] Individuals whose written informed consent has been obtained after explanation of this study. [4] Individuals who can have an examination on a designated check day [5]Individuals judged appropriate for the study by the principal.
Key exclusion criteria	[1] Individuals using medical products. [2] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [3] Individuals who have had a bad physical condition in the sauna bath in the past. [4] Individuals with strange skin conditions at measurement points. [5] Individuals with strange skin conditions at measurement points. [6] Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [7] Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [8] Individuals who contract or have a history of serious gastrointestinal disease. [9] Individuals with serious anemia. [10] Individuals whose BMI is over 30 kg/m2. [11] Individuals who are a smoker. [12] Individuals who have a habit of using sauna now or within the past 3 months. [13] Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [14] Individuals who have a habit to ingest health-promoting foods, or supplements containing similar composition with a test food in the past 3 months or will ingest those foods during the test period. [15] Individuals who have a habit to use Foods with Function Claims, functional foods and/or supplements claiming to improve cold sensitivity, blood flow, blood pressure, and thermal comfort effect in the past 3 months and/or are planning to use those foods during test periods. [16] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30mg/day). [17] Individuals whose observation date is menstrual [18] Individuals who had been conducted an operation or beauty treatment on the test spot. [19] Individuals who are or are possibly pregnant, or are lactating. [20] Individuals who participated in other clinical studies in the past 3 months. [21] Individuals judged inappropriate for the study by the principal.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Yukinobu Middle name Last name Shimamoto
Organization	CloudNine Inc.
Division name	Representative director
Zip code	730-0051
Address	1F Building Hirotake Otemachi, 2-2-9 Otemachi, Naka-ku, Hiroshima City, Hiroshima 730-0051, JAPAN
TEL	+81-82-545-5488
Email	shimamoto@cloud9-japan.com

Public contact
Name of contact person	1st name Ryoma Middle name Last name Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization	CloudNine Inc.
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	Ueno-Asagao Clinic Ethical Review Committee
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel	+81-3-6240-1162
Email	i.takahashi@tes-h.co.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	2022 Year 05 Month 12 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	Completed
Date of protocol fixation	2022 Year 05 Month 06 Day
Date of IRB	2022 Year 05 Month 09 Day
Anticipated trial start date	2022 Year 05 Month 17 Day
Last follow-up date	2022 Year 05 Month 18 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 05 Month 12 Day
Last modified on	2022 Year 11 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054402