UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036844 |
|---|---|
| Receipt number | R000041975 |
| Scientific Title | Examination of influence about sleep and feeling of fatigue by use of air conditioner and ventilation fans (2 groups comparison * 3 examination) |
| Date of disclosure of the study information | 2019/05/24 |
| Last modified on | 2019/09/18 19:52:15 |
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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
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
s.tsuji@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041975
