UMIN-CTR Clinical Trial

Basic information
Public title	The influence to sleep and feeling of fatigue by air conditioner and ventilation fans
Acronym	The influence to sleep and feeling of fatigue by air conditioner and ventilation fans
Scientific Title	Examination of influence about sleep and feeling of fatigue by use of air conditioner and ventilation fans (2 groups comparison * 3 examination)
Scientific Title:Acronym	Examination of influence about sleep and feeling of fatigue by use of air conditioner and ventilation fans
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effects on sleep and fatigue when using air conditioners and ventilation fans are compared and examined for each device condition.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Uchida-Kraepelin test The values on the first, second and third day of use in each phase are compared.
Key secondary outcomes	1. Purdue Pegboard Test 2. OSA sleep inventory MA version 3. Evaluation of mood and warmth 4. Fatigue VAS 5. Concentration VAS 6. Karolinska. Sleepiness Scale (KSS)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Control equipment - washout period - Test equipment
Interventions/Control_2	Test equipment - washout period - Control equipment
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	30 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Healthy males and females from 30 to 69 years of age (2) Subject who went to bedtime around 24 (3) Select from the lower total score of Zc value of OSA-MA at the time of pre-examination
Key exclusion criteria	(1) Subjects who constantly use test equipment (2) Subjects who do not use air conditioner at all in their daily lives (3) Subject presumed to have sleep disorder such as insomnia disorder (4) Subject who is not dissatisfied at all with recent sleep situation (5) Subjects who are ineligible for sleep testing in the population (6) Subjects who have daily activities and lifestyle habits that affect sleep and fatigue assessment (7) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (8) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (9) Subjects who intend to become pregnant or lactating (10) Female subject is not stable menstrual cycle (11) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size	36

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name Nishikawa
Organization	Panasonic Corporation Appliances Company
Division name	Residential Air-Conditioning Business Unit Advanced Technology Development Department
Zip code	525-8520
Address	2-3-1-1 Noji-higashi, Kusatsu City, Shiga
TEL	077-563-5211
Email	nishikawa.kazuo@jp.panasonic.com

Public contact
Name of contact person	1st name Shinsuke Middle name Last name Tsuji
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code	150-0021
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	s.tsuji@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd.
Institute
Department

Funding Source
Organization	Panasonic Corporation Appliances Company
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	Aisei Hospital Ueno Clinic Reserch Ethics Committee
Address	2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel	03-6455-0880
Email	t.saito@ttc-smo.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	2019 Year 05 Month 24 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	36
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	2019 Year 04 Month 25 Day
Date of IRB	2019 Year 04 Month 25 Day
Anticipated trial start date	2019 Year 05 Month 27 Day
Last follow-up date	2019 Year 09 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 05 Month 24 Day
Last modified on	2019 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041975