UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037593 |
|---|---|
| Receipt number | R000042717 |
| Scientific Title | Development of a new method for detecting sleep disordered breathing using audio data from polysomnography |
| Date of disclosure of the study information | 2019/08/05 |
| Last modified on | 2025/02/12 11:53:02 |
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Basic information
Public title
Development of a new method for detecting sleep disordered breathing using audio data from polysomnography
Acronym
Development of a new method for detecting sleep disordered breathing using audio data from polysomnography
Scientific Title
Development of a new method for detecting sleep disordered breathing using audio data from polysomnography
Scientific Title:Acronym
Development of a new method for detecting sleep disordered breathing using audio data from polysomnography
Region
| Japan |
Condition
Condition
sleep disordered breathing
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Developing a new method for detecting sleep disordered breathing (SDB) using audio data from polysomnography (PSG)
Basic objectives2
Others
Basic objectives -Others
To compare the apnea hypopnea index measured by the new method for detecting SDB and that measured by PSG
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of the apnea hypopnea index (AHI) measured by the new method for detecting SDB and that measured by PSG
Key secondary outcomes
1. Correlation of the apnea index measured by the new method for detecting SDB and that measured by PSG
2. Correlation of the hypopnea index measured by the new method for detecting SDB and that measured by PSG
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. There is no limit on age, sex, and medication.
2. Patients whose audio data from PSG could be analyzed
Key exclusion criteria
1. Patients with lack of clnical and examination data
Target sample size
132
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Chin |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Respiratory Care and Sleep Control Medicine
Zip code
606-8507
Address
Shogoin 54, Kawahara-cho, Kyoto
TEL
075-751-3852
chink@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Hamada |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Advanced Medicine for Respiratory Failure
Zip code
606-8507
Address
Shogoin 54, Kawahara-cho, Kyoto
TEL
075-366-7689
Homepage URL
sh1124@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Advanced Medicine for Respiratory Failure, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
The Last 5X innovation R and D center for a Smart, Happy, and a Resilient Society
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committe
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2019 | Year | 08 | Month | 05 | Day |
Related information
URL releasing protocol
https://kukonai.com/respiratory_failure
Publication of results
Unpublished
Result
URL related to results and publications
https://kyoto.bvits.com/rinri/publish_document.aspx?ID=4714
Number of participants that the trial has enrolled
20
Results
Using the accumulated audio data, we developed a method to calculate an estimated sleep disorder index that correlates with the apnea-hypopnea index (AHI) per hour of sleep in patients with sleep apnea.
Results date posted
| 2025 | Year | 02 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who underwent sleep examinations at the Department of Respiratory Medicine, Kyoto University Hospital.
Participant flow
Using audio data collected from sleep studies conducted in our department, we will perform an analysis to detect sleep-related breathing disorders.
Adverse events
None
Outcome measures
The number of sleep-disordered breathing events/hour.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2019 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective and observational one in patients with suspected sleep disordered breathing.
Management information
Registered date
| 2019 | Year | 08 | Month | 05 | Day |
Last modified on
| 2025 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042717
