UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058672 |
|---|---|
| Receipt number | R000066174 |
| Scientific Title | A Prospective Study on Early Detection of Cardiovascular Events via Remote Monitoring of Cheyne-Stokes Respiration |
| Date of disclosure of the study information | 2025/08/02 |
| Last modified on | 2026/10/11 14:19:09 |
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Basic information
Public title
A Prospective Study for Early Automated Detection of Cardiovascular Events Using CPAP Remote Monitoring Data in Patients with OSA
Acronym
Early Anomaly Detection of Cardiovascular Events Using CPAP Data
Scientific Title
A Prospective Study on Early Detection of Cardiovascular Events via Remote Monitoring of Cheyne-Stokes Respiration
Scientific Title:Acronym
Abnormality Detection Using CSR Signals
Region
| Japan |
Condition
Condition
Sleep apnea
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
| Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study continuously monitors the daily remote CPAP data of patients who have already been diagnosed with moderate to severe obstructive sleep apnea and are undergoing CPAP therapy. When a patient's data exceeds predefined thresholds, an anomaly alert is generated. The study aims to evaluate the effectiveness of this alert system for the early detection of actual cardiovascular events.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The study monitors three-day moving averages of parameters derived from remote CPAP monitoring data, such as the percentage of Cheyne-Stokes respiration. When predefined threshold criteria are exceeded, an anomaly alert is triggered. These alerts are then compared with the actual onset of cardiovascular events to evaluate the performance of the anomaly detection system.
Primary outcome measures include:
Accuracy,
Precision,
F measure.
Key secondary outcomes
The predefined threshold criteria will incorporate not only the absolute values of three-day moving averages (e.g., CSR%) but also the growth rate of these averages. Additional parameters such as air leakage and other relevant indicators will also be considered to identify optimal alert conditions.
Optimal cutoff values will be determined using receiver operating characteristic (ROC) curve analysis and the area under the curve (AUC). These methods will guide the selection of thresholds that maximize the accuracy of anomaly detection in relation to actual cardiovascular events.
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients currently undergoing treatment with the same CPAP device model at our institution.
Key exclusion criteria
Average CPAP usage rate less than 50%
Average CPAP usage time less than 4 hours
Target sample size
1300
Research contact person
Name of lead principal investigator
| 1st name | Kimimasa |
| Middle name | |
| Last name | Saito |
Organization
Medical Corporation MSC
Division name
Miesleep Clinic
Zip code
5190505
Address
446 sogo,obata,IseCity,Mie
TEL
0596290234
k1saito@carrot.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Kimimasa |
| Middle name | |
| Last name | Saito |
Organization
Medical Corporation MSC
Division name
Miesleep Clinic
Zip code
5190505
Address
446 Sogo, Obata-Chyo, Ise-shi, Mie
TEL
0596291159
Homepage URL
k1saito@carrot.ocn.ne.jp
Sponsor or person
Institute
Miesleep Clinic
Institute
Department
Personal name
Kimimasa Saito
Funding Source
Organization
MieSleep Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation MSC
Address
446 Sogo, Obata-Chyo, Ise-shi, Mie 519-0502, Japan
Tel
0596291159
ksaito.saito3@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
δΈιη
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1093/ehjdh/ztag108
Number of participants that the trial has enrolled
1265
Results
In 1265 CPAP-treated patients, retrospective analysis identified 25 cardiovascular/cerebrovascular events in 20 patients (HF 11, AF 7, cerebrovascular 7). D0 was 3 days before admission or outpatient intervention. During D-28 to D0, LTRI and/or ASA detected 92.0% of events (median lead time 12.0 days). Clinician-notification criteria detected 72.0% (6.5 days). Hierarchical filtering reduced notifications by 94.9% versus the baseline signal layer.
Results date posted
| 2026 | Year | 10 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 07 | Month | 02 | Day |
Baseline Characteristics
The single-centre cohort included 1265 patients with obstructive sleep apnoea undergoing CPAP telemonitoring between 19 August 2024 and 31 December 2025. Patients used the Philips Respironics DreamStation Auto BiPAP device, with data synchronized via eHomeCare and analysed using Care Orchestrator. Twenty patients experienced 25 adjudicated cardiovascular and cerebrovascular events.
Participant flow
The analytical cohort comprised 1265 patients. Twenty-five cardiovascular and cerebrovascular events occurring in 20 patients were analysed at the event level. Continuous deterioration without recovery was aggregated as a single event, whereas recurrent atrial fibrillation after restoration of sinus rhythm was treated as a separate event. Detailed numbers of exclusions and withdrawals were not reported in the published article.
Adverse events
This publication reports a retrospective observational analysis of CPAP telemonitoring data. Study-related adverse events were not tabulated or reported. The cardiovascular and cerebrovascular events were study outcomes and were not reported as adverse events caused by a study intervention.
Outcome measures
The published analysis evaluated event detection by LTRI and/or ASA within D28 to D0 and lead time from first detection to D0, with D0 defined as three days before hospital admission or outpatient intervention.
Additional measures included disease-specific detection rates, detection rates and lead times under clinician-notification criteria, day-level and episode-level false-positive rates after seven-day clustering, pre-event temporal patterns, and operational alert burden.
Plan to share IPD
Individual participant data will not be publicly available. Provision of de-identified data may be considered upon reasonable request and with appropriate institutional approval.
IPD sharing Plan description
The study data are not publicly available because they contain potentially identifiable patient information. De-identified data may be made available by the corresponding author upon reasonable request and with appropriate institutional approval.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 02 | Month | 05 | Day |
Date trial data considered complete
| 2026 | Year | 02 | Month | 11 | Day |
Date analysis concluded
| 2026 | Year | 02 | Month | 11 | Day |
Other
Other related information
Prospective validation using the optimized anomaly detection threshold will be conducted in approximately 1300 patients from October 2025 to September 2026. Time to event analysis will be performed using a Cox proportional hazards model to evaluate the predictive value of the detection for future cardiovascular events. Cumulative incidence of events will be visualized using Kaplan Meier survival curves.
Management information
Registered date
| 2025 | Year | 08 | Month | 01 | Day |
Last modified on
| 2026 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066174
