UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating the effect of sleep and fatigue using the air conditioner
Title of the study (Brief title)	A study for evaluating the effect of sleep and fatigue using the air conditioner
Region	Japan

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

Objectives
Narrative objectives1	To compare and evaluate the effect for sleep and fatigue using the air conditioner equipped with nanoeX or control device
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Uchida-Kraepelin test
Key secondary outcomes	Purdue Pegboard Test, OSA sleep inventory MA version, Quality of life assessment, Fatigue VAS, Concentration VAS

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Use of air conditioner equipped with nanoeX for 3 consecutive days - washout period of 1 week - use of control device for 3 consecutive days
Interventions/Control_2	use of control device for 3 consecutive days - washout period of 1 week - use of air conditioner equipped with nanoeX for 3 consecutive days
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	40 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Male and female aged from 40 to 69 2) Pittsburgh sleep quality index global score is under 6 3) The total score of the Zc of OSA sleep inventory MA version is low
Key exclusion criteria	1) Subjects who routinely use test device 2) Subjects who perform an act for the improvement of the quality of the sleep, the stress, and fatigue 3) Subjects who routinely intake foods that possibly affect sleep, stress, and fatigue 4) Subjects who are unsuitable for the sleep in the group 5) Subjects who needs aromatherapy etc. at bedtime 6) Subjects who wake after sleep onset for nocturia more than twice a week 7) Subjects who drink more than once a week 8) Subjects who smoke 9) Night and day shift worker or manual laborer 10) Subjects who have a disease under treatment or are judged to that medical treatment are necessary by the doctor 11) Subjects who have under treatment or a history of sleep apnea syndrome or is strongly suspected of sleep apnea syndrome 12) Subjects who have had a diagnosis of chronic fatigue syndrome 13) Subjects who have under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion 14) Subjects who have any discomfort in the wrist or arm 15) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and other questionnaires 16) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination 17) 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 18) Subjects who intend to become pregnant or lactating 19) Subjects judged as unsuitable for the current study by the investigator
Target sample size	12

Research contact person
Name of lead principal investigator	Hirona Miura
Organization	Higashi shinjyuku Clinic
Division name	Director
Address	1-11-3 Okubo Shinjuku-ku Tokyo
TEL	03-6233-8581
Email	koike@meiseikai-cl.com

Public contact
Name of contact person	Takashi Nakagawa
Organization	TTC Co.,Ltd.
Division name	Clinical Research Planning Department
Address	Seibu Shinkin Bank Ebisu Bldg., 1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	t.nakagawa@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co.,Ltd.
Institute
Department

Funding Source
Organization	Appliances company
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	2017 Year 07 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 08 Day
Anticipated trial start date	2017 Year 07 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 07 Month 04 Day
Last modified on	2017 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032132