UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000056750
Receipt number R000064854
Scientific Title A study of aroma control before and after sleep based on perceptions of aroma
Date of disclosure of the study information 2025/01/17
Last modified on 2025/01/17 19:41:30

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Basic information

Public title

A study of aroma control before and after sleep based on perceptions of aroma

Acronym

A study of aroma control before and after sleep based on perceptions of aroma

Scientific Title

A study of aroma control before and after sleep based on perceptions of aroma

Scientific Title:Acronym

A study of aroma control before and after sleep based on perceptions of aroma

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate the effects of the before and after aroma control on sleep restfulness.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sleep restfulness (the feeling rested after sleep)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

No aroma control

Interventions/Control_2

Sleep onset aroma control

Interventions/Control_3

Sleep onset and wake-up aroma control

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

35 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Aged between 35 and 65 years
2.Persons with any kind of sleep-related problem (difficulty falling asleep, nocturnal awakening, early morning awakening, etc.)
3.Persons who do not find the aroma of the test product unpleasant
4.Persons who have more than six hours of sleep duration (time in bed) per day

Key exclusion criteria

1.Currently taking (regularly using) medications for any of the following or has a chronic illness or disease under treatment.
1-a)An olfactory disorder
1-b)Cognitive dysfunction
1-c)Respiratory, neurological, or psychiatric disease
1-d)Chemical sensitivity
1-e)A sleep disorder
1-f)Heart disease
1-g)Pacemaker use
2.Engaged in shiftwork or keeps irregular hours (reversed sleep/wake cycle, etc.)
3.Prone to skin rashes (because the electrodes used for electrocardiography and simple electroencephalography are adhesive)
4.Participates in a competitive endurance sport such as distance running, swimming, or triathlon at an elite level (places high in competitions)

Target sample size

54


Research contact person

Name of lead principal investigator

1st name Sanae
Middle name
Last name Hanaoka

Organization

Daikin Industries, Ltd.

Division name

Technology and Innovation Center

Zip code

566-8585

Address

1-1, Nishi-Hitotsuya, Settsu, Osaka, 566-8585, Japan Daikin Industries, Ltd. Technology and Innovation Center

TEL

06-6195-7051

Email

sanae.hanaoka@daikin.co.jp


Public contact

Name of contact person

1st name Chiaki
Middle name
Last name Yasumoto

Organization

Daikin Industries, Ltd.

Division name

Technology and Innovation Center

Zip code

566-8585

Address

1-1, Nishi-Hitotsuya, Settsu, Osaka, 566-8585, Japan Daikin Industries, Ltd.Technology and Innovatio

TEL

06-6195-7051

Homepage URL


Email

chiaki.yasumoto@daikin.co.jp


Sponsor or person

Institute

Daikin Industries, Ltd.

Institute

Department

Personal name



Funding Source

Organization

Daikin Industries, Ltd.

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

Daikin Industries, Ltd.

Address

1-1, Nishi-Hitotsuya, Settsu, Osaka, 566-8585, Japan Daikin Industries, Ltd.Technology and Innovation Center

Tel

06-6195-7304

Email

rinrishinsa@daikin.co.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

2025 Year 01 Month 17 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

Open public recruiting

Date of protocol fixation

2024 Year 11 Month 07 Day

Date of IRB

2024 Year 12 Month 03 Day

Anticipated trial start date

2025 Year 01 Month 17 Day

Last follow-up date

2025 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2025 Year 01 Month 17 Day

Last modified on

2025 Year 01 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064854