UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059550 |
|---|---|
| Receipt number | R000068115 |
| Scientific Title | Prospective validation of automatic sleep staging using an EEG-based depth of anesthesia monitor and an open-source sleep staging toolbox |
| Date of disclosure of the study information | 2025/10/28 |
| Last modified on | 2025/10/27 13:30:57 |
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Basic information
Public title
Prospective validation of automatic sleep staging using an EEG-based depth of anesthesia monitor and an open-source sleep staging toolbox
Acronym
Prospective validation of automatic sleep staging using an EEG-based depth of anesthesia monitor and an open-source sleep staging toolbox
Scientific Title
Prospective validation of automatic sleep staging using an EEG-based depth of anesthesia monitor and an open-source sleep staging toolbox
Scientific Title:Acronym
Prospective validation of automatic sleep staging using an EEG-based depth of anesthesia monitor and an open-source sleep staging toolbox
Region
| Japan |
Condition
Condition
Sleep disorders
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the accuracy of automatic sleep staging using electroencephalographic (EEG) signals obtained from an EEG-based depth of anesthesia monitor, SedLine(R), and analyzed with an open-source automatic sleep staging toolbox, YASA.
The accuracy will be assessed by comparing the YASA-based sleep staging results with those obtained from polysomnography (PSG).
In patients suspected of having sleep disorders who undergo PSG, SedLine will be applied simultaneously. EEG signals collected from SedLine will be analyzed for sleep stages using the YASA algorithm. The PSG-based sleep staging results will then be compared with those derived from SedLine. The primary outcome will be the level of agreement between the two sleep staging methods, expressed as Cohen's kappa coefficient.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cohen's kappa.
Key secondary outcomes
sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Adults aged 18 years or older at the time of obtaining informed consent
2. Patients scheduled to undergo polysomnography
Key exclusion criteria
1. Patients who are unable or unwilling to provide informed consent
2. Patients with central nervous system disorders (e.g., cognitive impairment, epilepsy, brain tumour, or psychiatric disorders)
3. Patients who are highly likely to be unable to remain still during the examination
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Hasegawa |
Organization
Fukushima Medical University
Division name
Department of Anesthesiology
Zip code
9601295
Address
1 Hikarigaoka, Fukushima City, Fukushima, JAPAN
TEL
0245471111
masui@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Hasegawa |
Organization
Fukushima Medical University
Division name
Department of Anesthesiology
Zip code
9601295
Address
1 Hikarigaoka, Fukushima City, Fukushima, JAPAN
TEL
0245471111
Homepage URL
masui@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
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
Fukushima Medical University Research Ethics Committee
Address
1 Hikarigaoka, Fukushima city, Fukushima
Tel
024-547-1825
fmurec@fmu.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 | 10 | Month | 28 | 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
| 2025 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2030 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Before initiation
Management information
Registered date
| 2025 | Year | 10 | Month | 27 | Day |
Last modified on
| 2025 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068115
