UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056169 |
|---|---|
| Receipt number | R000064178 |
| Scientific Title | Sleep quality improvement test by wearing Nerugoo (rechargeable hot eye mask) |
| Date of disclosure of the study information | 2024/11/15 |
| Last modified on | 2025/03/17 17:44:55 |
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Basic information
Public title
Sleep quality improvement test by wearing Nerugoo (rechargeable hot eye mask)
Acronym
Sleep quality improvement test by wearing Nerugoo (rechargeable hot eye mask)
Scientific Title
Sleep quality improvement test by wearing Nerugoo (rechargeable hot eye mask)
Scientific Title:Acronym
Sleep quality improvement test by wearing Nerugoo (rechargeable hot eye mask)
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of wearing Nerugoo (rechargeable hot eye mask) on sleep in Japanese men and women aged 20 to 70 years old.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep quality (electroencephalogram measurement)
Key secondary outcomes
(Secondary outcomes)
Sleep quality VAS questionnaire , OSA sleep inventory MA version
(Safety evaluation)
Adverse events
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Wearing the test product for 5 days at a heated temperature - Washout period (1 week) - Wearing the test product for 5 days without heating
Interventions/Control_2
Wearing the test product for 5 days without heating - Washout period (1 week) - Wearing the test product for 5 days at a heated temperature
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese men and women between the ages of 20 and 70 at the time consent is obtained
2) Subjects who are aware of poor sleep quality.
3) Subjects who have received a thorough explanation of their participation in this study, and who have given written consent of their own free will based on a thorough understanding of the study.
Key exclusion criteria
1) Subjects who are under medication or outpatient treatment for some serious disease.
2) Subjects who are on exercise or diet therapy under the supervision of a physician.
3) Subjects who are likely to develop some adverse effects in their daily life due to the tested product.
4) Subjects with a current or previous history of drug or alcohol dependence.
5) Subjects who are currently visiting the hospital for mental disorders (depression, etc.) or sleep disorders (insomnia, sleep apnea syndrome, etc.), or who have a history of mental illness in the past.
6) Subjects who have an irregular rhythm of life due to night work, shift work, etc.
7) Subjects who have an extremely irregular lifestyle in terms of eating, sleeping, etc.
8) Subjects who have an extremely picky eater.
9) Subjects with a serious current or previous illness such as brain disease, malignant tumor, immunological disease, diabetes, liver disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal gland disease, or other metabolic disease.
10) Subjects who use health foods, supplements, or medicines that affect the quality of sleep.
11) Subjects who use devices that claim to improve sleep quality, such as hot eye masks.
12) Subjects who have participated in other clinical trials (research) within 3 months prior to the date of consent, or have plans to participate in other clinical trials (research) during the study period.
13) Subjects with facial nerve disorder, skin sensory disorder, allergic constitution, skin disease, and atopic dermatitis, or sensitive skin.
14) Subjects who have undergone implantation surgery on the face due to bone fracture, plastic surgery, etc.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Shirai |
Organization
Lulu Inc.
Division name
CEO
Zip code
541-0058
Address
4-1-2 Minamikyuhojimachi Chuo-ku, Osaka-shi, Osaka-fu, Japan
TEL
06-6251-0391
shirai@nerugoo.jp
Public contact
Name of contact person
| 1st name | Mayuko |
| Middle name | |
| Last name | Nouchi |
Organization
Medical Corporation Taifukukai, Osaka Nishiumeda Clinic
Division name
Clinical Trial Center
Zip code
530-0001
Address
Maruito Nishi-Umeda Building 3F 3-3-45 Umeda Kita-ku, Osaka-shi, Osaka-fu, Japan
TEL
06-4797-5660
Homepage URL
crc@ml.taifukukai.jp
Sponsor or person
Institute
Medical Corporation Taifukukai, Osaka Nishiumeda Clinic
Institute
Department
Personal name
Funding Source
Organization
Lulu Inc.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Shinjuku Clinic Ethical Review Board
Address
SIL Shinjuku 5F, 2-46-3, Kabukicho, Shinjuku-ku, Tokyo,Japan
Tel
03-6709-6071
irb@ml.taifukukai.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
| 2024 | Year | 11 | Month | 15 | 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
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 09 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 09 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2025 | Year | 02 | Month | 28 | Day |
Other
Other related information
(Exclusion criteria continued)
15) Subjects who are not aware of heat
16) Subjects with head or ophthalmologic sequelae due to traffic accidents, etc.
17) Subjects who have or have had eye diseases or eye surgery.
18) Subjects who may experience hay fever symptoms during the test period.
19) Subjects with trauma to the eye area where the test article is worn.
20) Subjects with frequent urination at night (more than 2 interruptions of sleep due to urination)
21) Subjects who are currently pregnant or lactating, or subjects who may be so during the study period.
22) Subjects who have difficulty in complying with recording on various investigation forms
23) Subjects who are judged to be unsuitable as subjects based on clinical laboratory values and measurements at the time of SCR
24) Other subjects who are judged to be unsuitable as subjects by the investigator.
Management information
Registered date
| 2024 | Year | 11 | Month | 15 | Day |
Last modified on
| 2025 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064178
