UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042555 |
|---|---|
| Receipt number | R000048573 |
| Scientific Title | To examine the usefulness of CSR monitoring as a predictor of cardiac disease in OSA patients undergoing CPAP treatment. A Case-Control Study |
| Date of disclosure of the study information | 2021/01/01 |
| Last modified on | 2022/02/11 16:30:39 |
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Basic information
Public title
To examine the usefulness of CSR monitoring as a predictor of cardiac disease in OSA patients undergoing CPAP treatment.
A Case-Control Study
Acronym
Efficacy of CSR Remote Monitoring
Scientific Title
To examine the usefulness of CSR monitoring as a predictor of cardiac disease in OSA patients undergoing CPAP treatment.
A Case-Control Study
Scientific Title:Acronym
Efficacy of CSR Remote Monitoring
Region
| Japan |
Condition
Condition
Sleep apnea syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether increased or fluctuating CSR can be an early predictor of cerebrovascular and heart disease in OSA patients on CPAP treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Using data from CPAP software downloads, we examined the association between %CSR, CSR variability every 3-7 days, and various respiratory indices and new onset of cerebrovascular or cardiac disease, exacerbation of chronic heart failure, onset or recurrence of atrial fibrillation, and sudden death during sleep. We defined the event-onset group as cases with new onset of cerebrovascular or cardiac disease and sudden death during sleep during the 3-year period 2018-2020, and examined factors influencing these events compared with a control group that did not develop these events in 2020.
Key secondary outcomes
The CSR% and CSR variability in the control group were determined.
We examined the usefulness of monitoring CSR%, variability, and various respiratory event indices in predicting the onset of 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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) OSA patients who received CPAP treatment in our clinic from January 2018 to December 2020.
2) OSA patients with AHI 20 or greater at PSG.
3) Patients who have received informed consent.
Key exclusion criteria
1)Major uncontrolled medical or psychiatric conditions
2)The presence of untreated and diagnosable non-OSA sleep disorders (e.g., restless leg syndrome, insomnia, PLMD).
3)Current shift work
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | KIMIMASA |
| Middle name | |
| Last name | SAITO |
Organization
Mie Sleep Clinic
Division name
Depertment of Respiratory
Zip code
5190502
Address
446 sogo obata Ise,MIe
TEL
+81-596-29-1159
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
Mie Sleep Clinic
Zip code
5190502
Address
446 sogo obata Ise,MIe
TEL
+81-596-29-1159
Homepage URL
k1saito@carrot.ocn.ne.jp
Sponsor or person
Institute
Medical corporation MSC
Mie Sleep Clinic
Institute
Department
Personal name
Funding Source
Organization
Medical corporation MSC
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
Medical corporation MSC
Address
446 sogo obata Ise,MIe
Tel
+81-596-29-1159
k1saito@carrot.ocn.ne.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
| 2021 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s11325-021-02510-0
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/articles/10.3389/fcvm.2022.790331
Number of participants that the trial has enrolled
775
Results
The median CSB% in stable patients on CPAP treatment was low at 0.32%, with only 24% of patients having CSB% 1% or more. The HF group demonstrated greater CSB variations and longer CL than the non-HF control group. Furthermore, the CL was longer during the exacerbation period of HF even in the same patient.
Results date posted
| 2022 | Year | 02 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
775 patients who had used the Auto CPAP machine for at least 1 year at Mie Sleep Clinic as of September 1, 2020. All patients were diagnosed with OSA, with an apnea-hypopnea index (AHI) 20 or more by overnight polysomnography, or with sleep apnea syndrome, predominantly of the obstructive type, with AHI 40 or more by out-of-center sleep testing, and had been continuously treated with CPAP.
Participant flow
Exclusion criteria were as follows: age 90 years or more as of September 1, 2020; poor-adherence patients with the percentage of days of CPAP use less than 50% or an average CPAP use time <4 h; new onset of HF, worsening of CHF, or new onset or relapse of atrial fibrillation (Af), or other cardiovascular diseases in the 3 months before or after September 1, 2020 (i.e., between June 1, 2020 and November 30, 2020).
Adverse events
None
Outcome measures
The primary endpoint was the calculation of standard data, such as the monthly median CSB%, and the analysis of factors associated with CSB in patients with stable OSA on CPAP.
And we examined whether remote monitoring of CSB was useful for predicting the onset of HF in patients with OSA on CPAP.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
January 1, 2018 to December 31, 2020
Management information
Registered date
| 2020 | Year | 11 | Month | 25 | Day |
Last modified on
| 2022 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048573
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