UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056211 |
|---|---|
| Receipt number | R000064225 |
| Scientific Title | Sleep evaluation using an electroencephalograph while using earplug-type products at home |
| Date of disclosure of the study information | 2024/11/20 |
| Last modified on | 2024/11/20 13:36:01 |
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Basic information
Public title
Sleep evaluation using an electroencephalograph while using earplug-type products at home
Acronym
Sleep evaluation using an electroencephalograph while using earplug-type products at home
Scientific Title
Sleep evaluation using an electroencephalograph while using earplug-type products at home
Scientific Title:Acronym
Sleep evaluation using an electroencephalograph while using earplug-type products at home
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of earplug heating on sleep quality
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep measurement data
Key secondary outcomes
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Sleeping with heat-generating earplugs
Sleeping with non-heating earplugs
Interventions/Control_2
Sleeping with non-heating earplugs on
Sleeping with heating earplugs on
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
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those aged 20 years or older and 55 years or younger at the time of obtaining consent
Those who are dissatisfied with their sleep
Those who sleep in bed every day
Those who can sleep alone during the study period
Those who have received an explanation of the study and have fully understood it before participating, and have given written consent
PSQI (Pittsburgh Sleep Quality Index): 4-8 points
STAI (Trait Anxiety Scale): trait anxiety 33-55 points
Key exclusion criteria
BMI less than 18.5 or 30.0 or more
Those with symptoms of sleep apnea syndrome or diagnosed with a sleep disorder
Those who wish to participate in the following activities on the day of the study and during the study period
Drinking alcohol Excessive exercise Caffeine intake after 6 p.m. Smoking
Those who regularly use any medicine or use medical devices
Those who are primarily responsible for childcare or elderly care
Those who live with or keep pets
Those who have used the test product in the past and experienced some abnormality when using it
Those with ear disorders
Those who are deemed inappropriate by the research staff
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Ryui |
| Middle name | |
| Last name | Kiyoe |
Organization
Kobayashi Pharmaceutical Co., Ltd.
Division name
Household Products Division Wellness Care R&D Group
Zip code
567-0057
Address
1-30-3,Toyokawa, Ibaraki-city, Osaka, Japan
TEL
080-3452-9751
r.kiyoe@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Miyu |
| Middle name | |
| Last name | Okano |
Organization
Kobayashi Pharmaceutical Co., Ltd.
Division name
Household Products Division Wellness Care R&D Group
Zip code
567-0057
Address
1-30-3,Toyokawa, Ibaraki-city, Osaka, Japan
TEL
08091231774
Homepage URL
mi.okano@kobayashi.co.jp
Sponsor or person
Institute
Kobayashi Pharmaceutical Co., Ltd.
Household Products Division Wellness Care R&D Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
ASMARQ Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.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 | 11 | Month | 20 | 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 | 11 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 20 | 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 | 11 | Month | 20 | Day |
Last modified on
| 2024 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064225
