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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041975


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name