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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042555
Receipt No. 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 2020/12/29

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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
Email 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
Email k1saito@carrot.ocn.ne.jp

Sponsor
Institute Medical corporation MSC
Mie Sleep Clinic
Institute
Department

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
Email 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
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 No longer recruiting
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
2020 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048573

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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