UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052386 |
|---|---|
| Receipt number | R000059803 |
| Scientific Title | Development of sleep stages estimation method using cardiovascular indicators |
| Date of disclosure of the study information | 2023/10/03 |
| Last modified on | 2024/06/07 12:22:21 |
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Basic information
Public title
Development of sleep stages estimation method using cardiovascular indicators
Acronym
Development of sleep stages estimation method using cardiovascular indicators
Scientific Title
Development of sleep stages estimation method using cardiovascular indicators
Scientific Title:Acronym
Development of sleep stages estimation method using cardiovascular indicators
Region
| Japan |
Condition
Condition
Healthy participant
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a technology to determine sleep stages using an earplug or ring-type blood flow meter
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection accuracy of sleep stage 2 and sleep stage 3 emergence timing evaluated using Kyocera blood flow and acceleration sensors
Key secondary outcomes
1. Sleep stages obtained by visual sleep staging by a clinical laboratory technician after obtaining biometric data from electroencephalography, electrooculography, electromyography, etc. of polysomnography
2. Kyocera's blood flow and acceleration sensors to be developed by Kyocera to evaluate the feeling of wearing them, their effect on sleep, etc.
3. Questionnaires (Morningness Eveningness Questionnaire, Pittsburgh Sleep Quality Index, OSA sleep inventory)
4. Evaluation of sleep with MotionWatch 8 by CamNtech Ltd and Oura Ring 3 by Oura Health Oy.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Having no difficulty in filling out Japanese explanatory documents, consent forms, and survey forms
2. No claustrophobia and being able to stay in the examination room on the 5th floor of the Innovation Medical Research Institute, University of Tsukuba.
3. Currently having no symptoms or no history for sleep disorder
Key exclusion criteria
1. Irregular lifestyle (A guideline for regular life: 21: 00 ~ 1: 00 going to bed, getting up from 6: 00 ~ 9: 00)
2. BMI less than 18.5
3. Worked night shift (after 22:00) within the last 3 months
4. Having traveled to a country with a time difference of 3 hours or more within the last 3 months
5. Drink alcohol regularly (at least 40 g of pure alcohol [approximate: 2 cans of beer] twice a week or more)
6. Having a smoking habit
7. Daily caffeine intake of 300 mg or more (approximate: 5 cups of 150 mL coffee)
8.Morningness-Eveningness Questionnaire (MEQ) score 30 points or less or 70 points or above
9. Claustrophobia
10. Pregnant or its possibility
11. Lactation
12. Those who have a disease that may change suddenly or have a history
13. Those who have been treated for mental illness or sleep disorders, those who have symptoms that are currently being treated
14. Participant judged by the investigator to be inappropriate
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Abe |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine (WPI-IIIS)
Zip code
3050821
Address
Innovation Medical Research Institute 502, 1-2 Kasuga, Tsukuba, Ibaraki
TEL
029-859-1469
abe.takashi.gp@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | Medicine Takashi |
| Last name | Abe |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine (WPI-IIIS)
Zip code
3050821
Address
Innovation Medical Research Institute 502, 1-2 Kasuga, Tsukuba, Ibaraki
TEL
029-859-1469
Homepage URL
abe.takashi.gp@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
KYOCERA 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
The Clinical Research Ethics Review Committee of the University of Tsukuba Hospital
Address
1-1-1 Tennnodai, Tsukuba, Ibaraki
Tel
029-853-3914
rinshokenkyu@un.tsukuba.ac.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
| 2023 | Year | 10 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
45
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
| 2022 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The detection accuracy of sleep stage 2 and sleep stage 3 emergence timing is evaluated using Kyocera blood flow and acceleration sensors. Using the sleep stage determination obtained from the polysomnogram as the gold standard, the latencies of sleep stages 2 and 3 assessed using Kyocera blood flow and acceleration sensors are compared with the polysomnogram.
Management information
Registered date
| 2023 | Year | 10 | Month | 03 | Day |
Last modified on
| 2024 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059803
