UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056235 |
|---|---|
| Receipt number | R000064254 |
| Scientific Title | Verification of Sleep Respiratory Event Detection Using the Smartphone Application "SAS'Eye": A Comparison of Accuracy with Polysomnography |
| Date of disclosure of the study information | 2024/11/25 |
| Last modified on | 2025/05/26 10:31:30 |
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Basic information
Public title
Verification of the Utility of Sleep Respiratory Event Detection Using the Smartphone Application "SAS'Eye"
Acronym
Verification of the Utility of Sleep Respiratory Event Detection Using Smartphone APP
Scientific Title
Verification of Sleep Respiratory Event Detection Using the Smartphone Application "SAS'Eye": A Comparison of Accuracy with Polysomnography
Scientific Title:Acronym
Verification of Sleep Respiratory Event Detection Using the Smartphone Application "SAS'Eye": A Comparison of Accuracy with Polysomnography
Region
| Japan |
Condition
Condition
Patients with Suspected Sleep Disorders
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the screening accuracy of SAS'Eye by examining the correlation between Sleep Apnea Syndrome related variables including the Apnea Hypopnea Index and SAS'Eye analysis data, using breathing sounds recorded by smartphone during polysomnography.
Basic objectives2
Others
Basic objectives -Others
Evaluation of screening accuracy
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1 Screening capability for mild or more severe SAS cases analyzed using the SAS'Eye algorithm
2 AHI more than or equal 5 indicating mild or more severe SAS detected through analysis using Sleepware G3 which is automated analysis software by Philips from measurements taken by polysomnography.
Evaluate the concordance between 1 and 2.
Key secondary outcomes
1 SAS events which are OSA, CSA, and Hypopnea detected by the SAS'Eye algorithm
2 SAS events which are OSA, CSA, and Hypopnea detected through analysis using Sleepware G3 which is automated analysis software by Philips from measurements taken by PSG
Evaluate the concordance between 1 and 2
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
Participants will include individuals who undergo PSG testing at our hospital from the research start date (December 1st, 2024 planning) until March 31, 2026, and who have not indicated refusal for the use or provision of their medical information for this research purpose. Note that minors will not be included in this study.
Key exclusion criteria
Individuals who have indicated refusal for the use or provision of their medical information, and those deemed ineligible by the principal investigator or co-investigators.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Kuriyama |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
0423462014
kenichik@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Utsumi |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
0423462014
Homepage URL
t-utsumi@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
D'isum Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
D'isum Inc.
Name of secondary funder(s)
Nothins
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry Ethics Committee
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
Tel
042-341-2712
rinri-jimu@ncnp.go.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
国立精神・神経医療研究センター
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 25 | 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
| 2024 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
Study Design: Prospective observational study
Recruitment Method: Recruitment of patients with suspected sleep disorders who will undergo PSG testing at our hospital from December 1st, 2024, to March 31, 2026.
Evaluation Items: Refer to Primary and Secondary Outcome Measures.
Management information
Registered date
| 2024 | Year | 11 | Month | 22 | Day |
Last modified on
| 2025 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064254
