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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046232
Receipt No. R000052757
Scientific Title The study of sleep deprivation in human: an open-label trial
Date of disclosure of the study information 2021/11/30
Last modified on 2021/11/30

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Basic information
Public title The study of sleep deprivation in human
Acronym The study of sleep deprivation in human
Scientific Title The study of sleep deprivation in human: an open-label trial
Scientific Title:Acronym The study of sleep deprivation in human
Region
Japan

Condition
Condition Healthy Japanese subjects
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effects of sleep deprivation on salivary biomarker in healthy Japanese subjects
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. The measured value of metabolome analysis of salivary after sleep deprivation
Key secondary outcomes 1. The amount of change of metabolome analysis of salivary from screening (before sleep deprivation; Scr) to after sleep deprivation

2. The measured values and amount of change from Scr in each items of sleep test (Sleep Scan) after sleep deprivation

3. The measured values and amount of change from Scr in each items of Pittsburgh Sleep Quality Index (PSQI ) after sleep deprivation

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Duration: One week
Intervention: Sleep for five hours in daily for seven days
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Japanese

2. Male or female

3. Subjects aged 20 or more

4. Healthy subjects

5. Subjects who usually sleep for approximately eight hours

6. Subjects who are judged as eligible to participate in the study by the physician
Key exclusion criteria 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Subjects currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Subjects who live with their infants less than one year old

5. Subjects who co-sleep with their children (one to six years old)

6. Subjects whose sleeping time or habit is irregular due to working a late-night shift

7. Subjects who wake up for urination three times or more during nocturnal sleep

8. Subjects who have the opportunity to drive (passenger cars, motorcycles, buses, trains, airplanes, other vehicles that require a license, bicycles, and kick scooters) during the study

9. Subjects who may intensely exercise during the study

10. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use

11. Subjects currently taking medicines (include herbal medicines) and supplements

12. Subjects who are allergic to medications

13. Subjects who are pregnant, breast-feeding, and planning to become pregnant

14. Subjects who suffer from COVID-19

15. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

16. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Tsuyoshi
Middle name
Last name Takara
Organization Medical Corporation Seishinkai, Takara Clinic
Division name Director
Zip code 141-0022
Address 9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL 03-5793-3623
Email t-takara@takara-clinic.com

Public contact
Name of contact person
1st name Naoko
Middle name
Last name Suzuki
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code 112-0002
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization National Institute of Advanced Industrial Science and Technology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel 03-5793-3623
Email IRB@takara-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 医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 30 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
2021 Year 11 Month 17 Day
Date of IRB
2021 Year 11 Month 17 Day
Anticipated trial start date
2021 Year 11 Month 30 Day
Last follow-up date
2022 Year 01 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 11 Month 30 Day
Last modified on
2021 Year 11 Month 30 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052757

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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