UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057274 |
|---|---|
| Receipt number | R000045230 |
| Scientific Title | Evaluation of brain lymphatics related to sleep by using MRI |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/13 11:32:53 |
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Basic information
Public title
Evaluation of brain lymphatics related to sleep by using MRI
Acronym
Evaluation of brain lymphatics related to sleep by using MRI
Scientific Title
Evaluation of brain lymphatics related to sleep by using MRI
Scientific Title:Acronym
Evaluation of brain lymphatics related to sleep by using MRI
Region
| Japan |
Condition
Condition
Sleep Apnea Syndrome
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Three MRI-based methods can be considered for evaluating changes in the brain's lymphatic system associated with obstructive sleep apnea syndrome (hereafter referred to as sleep disorder):
1. **Evaluation using diffusion imaging: Primary evaluation item**
Assessment of changes in the ALPS index before and after sleep, as well as after treatment in the disease group, using the DTI-ALPS method with diffusion imaging.
Basic objectives2
Others
Basic objectives -Others
2. **Evaluation using magnetization transfer imaging**
Assessment of changes in the distribution of mobile proteins in the brain using amide proton transfer MRI signal intensity images.
3. **Evaluation using perfusion imaging with gadolinium contrast agent**
Assessment of changes in cerebral blood flow and cerebral blood volume using MRI perfusion imaging.
This evaluation will only be conducted on patients who provide consent for contrast-enhanced imaging and will be considered as a supplementary measure to the above two methods.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
In this study, to establish an evaluation method for the brain's lymphatic system, we will compare the individual assessment capabilities of the three evaluation methods in patients with obstructive sleep apnea syndrome and a normal control group. Additionally, we will examine the usefulness of a comprehensive evaluation combining all three methods.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Individuals aged 18 years or older and under 50 who are scheduled for an evaluation of central nervous system abnormalities using the 3T MRI at the affiliated hospital for the diagnosis of sleep disorders, and who understand the study details and consent to participate, will be included as subjects.
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals aged 18 years or older and under 50 who are scheduled for an evaluation of central nervous system abnormalities using the 3T MRI at the affiliated hospital for the diagnosis of sleep disorders, and who understand the study details and consent to participate, will be included as subjects.
Key exclusion criteria
1) Individuals with internal or superficial metal due to surgery or trauma (e.g., ferromagnetic cerebral aneurysm clips, intraocular metal [history of metalwork], artificial heart valves, implants, dentures with magnets, artificial joints, endoscopic clips, fracture fixation metal, bullets, ocular prostheses with magnets, implanted acupuncture needles, etc.).
2) Individuals with implanted electronic devices (e.g., cardiac pacemakers, cochlear implants, implantable defibrillators, implanted neurostimulators, bone growth stimulators, etc.).
3) Individuals with tattoos or permanent eyeliner.
4) Individuals with claustrophobia.
5) Individuals who are pregnant or may be pregnant.
6) Individuals wearing underwear that may generate heat during imaging, such as Heattech.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Taoka |
Organization
Nagoya University, Graduate scholl of medicine
Division name
Department of innovative biomedical visualization
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2327
ttaoka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiaki |
| Middle name | |
| Last name | Taoka |
Organization
Nagoya University, Graduate scholl of medicine
Division name
Department of innovative biomedical visualization
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2327
Homepage URL
ttaoka@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Canon Medical Systems
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2327
ttaoka@med.nagoya-u.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
| 2025 | Year | 04 | Month | 01 | 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
50
Results
A multiple regression analysis adjusted for age was performed to evaluate the relationship between diffusion factors in the **ALPS White Matter Region** and the **ALPS index**. As expected, factors within the **ALPS White Matter Region** had a significant impact. Interestingly, **assocDyy** and **projDzz**, which are not directly involved in the calculation of the **ALPS index**, were also found to have an influence.
Results date posted
| 2025 | Year | 03 | Month | 13 | Day |
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 13 | Day |
Last modified on
| 2025 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045230
