UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054194 |
|---|---|
| Receipt number | R000061887 |
| Scientific Title | Sleep improvement effect of reducing bedroom odor using deodorizer: randomized |
| Date of disclosure of the study information | 2024/05/08 |
| Last modified on | 2024/04/19 00:37:02 |
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Basic information
Public title
Effect of the deodorizing bedding on sleep.
Acronym
Effect of the deodorizing bedding on sleep.
Scientific Title
Sleep improvement effect of reducing bedroom odor using deodorizer: randomized
Scientific Title:Acronym
Effect of the deodorizing bedding on sleep.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the Effectiveness of Deodorizers for Sleep Discomfort Caused by Bedroom Odor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Slow-wave sleep latency
Key secondary outcomes
-Sleep Stages Proportions:
the distribution of sleep stages, including N1, N2, N3, and REM.
-Sleep efficiency
-Relative EEG Band Power:
the relative power of different EEG frequency bands (alpha, beta, gamma, delta, and theta) during each sleep stage.
-Correlation between compliments related to bedroom odor, subjective sleep quality, and subjective fatigue scores using a visual analog scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Apply a deodorizer to the bedroom once a day for a week.
Interventions/Control_2
Apply placebo water to the bedroom once a day for a week.
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy males and females aged 20-59.
2. Person whose Athens Insomnia Scale(AIS) score is greater than 4.
3. Person who moderately or strongly perceives an unpleasant odor in the bedroom.
4. Person who moderately or strongly perceives an unpleasant odor from bedding.
5. Person who has had trouble falling asleep due to an unpleasant odor in the bedroom or from bedding.
6. Person who does not regularly use deodorizers on bedding.
Key exclusion criteria
1. Person who cannot properly wear or use an EEG recording device.
2. Person with allergies specifically related to medical tape or rubber materials.
3. Person who shares a bed with an infant aged less than one year.
4. Woman who is either pregnant or currently breastfeeding.
5. Person with frequent nocturnal awaking due to multiple nighttime urinations (3 or more)
6. Person who regularly takes Foods with Functional Claims specifically related to sleep.
7. Person who takes medications related to sleep.
8. Person who is currently involved in other clinical trials or investigations.
9. Person with any other ineligibility determined by the investigators.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hironori |
| Middle name | |
| Last name | Kojima |
Organization
Kao Corporation
Division name
Household Products Research Lab.
Zip code
640-8580
Address
1334, Minato, Wakayama-city, Wakayama, 640-8580, JAPAN
TEL
+81-70-3301-1768
kojima.hironori@kao.com
Public contact
Name of contact person
| 1st name | Michitaka |
| Middle name | |
| Last name | Inoue |
Organization
Kao Corporation
Division name
Household Products Research Lab.
Zip code
640-8580
Address
1334, Minato, Wakayama-city, Wakayama, 640-8580, JAPAN
TEL
+81-70-3300-7057
Homepage URL
inoue.michitaka@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
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
| 2024 | Year | 05 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 04 | 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
| 2024 | Year | 04 | Month | 19 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061887
