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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028063
Receipt No. R000032132
Scientific Title A study for evaluating the effect of sleep and fatigue using the air conditioner
Date of disclosure of the study information 2017/07/04
Last modified on 2017/12/03

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Basic information
Public title A study for evaluating the effect of sleep and fatigue using the air conditioner
Acronym A study for evaluating the effect of sleep and fatigue using the air conditioner
Scientific Title A study for evaluating the effect of sleep and fatigue using the air conditioner
Scientific Title:Acronym 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
1st name
Middle name
Last name Hirona Miura
Organization Higashi shinjyuku Clinic
Division name Director
Zip code
Address 1-11-3 Okubo Shinjuku-ku Tokyo
TEL 03-6233-8581
Email koike@meiseikai-cl.com

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Nakagawa
Organization TTC Co.,Ltd.
Division name Clinical Research Planning Department
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2017 Year 06 Month 08 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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