UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024295 |
|---|---|
| Receipt number | R000027946 |
| Scientific Title | Evaluating the severity of sleep disordered breathing based on cyclic variation of heart rate (CVHR) score |
| Date of disclosure of the study information | 2016/10/15 |
| Last modified on | 2026/04/12 10:13:04 |
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Basic information
Public title
Evaluating the severity of sleep disordered breathing based on cyclic variation of heart rate (CVHR) score
Acronym
Evaluating the severity of sleep disordered breathing based on cyclic variation of heart rate (CVHR) score
Scientific Title
Evaluating the severity of sleep disordered breathing based on cyclic variation of heart rate (CVHR) score
Scientific Title:Acronym
Evaluating the severity of sleep disordered breathing based on cyclic variation of heart rate (CVHR) score
Region
| Japan |
Condition
Condition
sleep disordered breathing
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between CVHR score obtained in the Holter electrocardiogram and severity of sleep disordered breathing (SDB), and the association between CVHR score and hemodynamic parameters obtained non invasively and simultaneously with using digital photoplethsmography
Basic objectives2
Others
Basic objectives -Others
Exporatoly
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
apnea hypopnea index
CVHR score
blood pressure
cardiac output
total peripheral resistance
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing overnight polysomnography in the department of Cardiovascular Medicine, Juntendo University Hospital
Key exclusion criteria
1. Patients with cardiac pacemaker implantation
2. Patients who have a difficulty to wear Holter electrocardiography
3. Patients who are considered as inappropriate based on the principle investigator's judgement
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takatoshi |
| Middle name | |
| Last name | Kasai |
Organization
Juntendo University
Division name
Cardiovascular Respiratory Sleep Medicine
Zip code
113-8421
Address
3-1-3 Hongo Bunkyo-ku Tokyo
TEL
0338133111
kasai-t@mx6.nisiq.net
Public contact
Name of contact person
| 1st name | Takatoshi |
| Middle name | |
| Last name | Kasai |
Organization
Juntendo University
Division name
Cardiovascular Respiratory Sleep Medicine, Juntendo University Graduate School of Medicine
Zip code
113-8421
Address
3-1-3 Hongo Bunkyo-ku Tokyo
TEL
0338133111
Homepage URL
kasai-t@mx6.nisiq.net
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
We have no funding source
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of the Juntendo University Hospital
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5802-1584
kenkyu5858@juntendo.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
| 2016 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/34013882/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34013882/
Number of participants that the trial has enrolled
101
Results
The CVHR score was significantly correlated with the apnea-hypopnea index (r = .667, P < .001) and limits of agreement between the apnea-hypopnea index and CVHR score were -21.8 to 35.2.
Results date posted
| 2026 | Year | 04 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We enrolled consecutive patients with and without HF who underwent full polysomnographies with simultaneous Holter electrocardiogram monitoring.
Participant flow
This study was a prospective, single-center, observational study at the Sleep and SleepDisordered Breathing Center and the Department of Cardiovascular Medicine of Juntendo University Hospital in Tokyo, Japan. All the participants simultaneously underwent overnight polysomnography and Holter electrocardiogram during a onenight hospital stay. Polysomnographic data and Holter electrocardiogram data were synchronized by aligning the Holter electrocardiogram recording time with the corresponding polysomnography recording time. The polysomnographic scoring and synchronization of time for heart rate analysis were performed by two independent investigators, each one blinded to the results of the other.
Adverse events
This study is an interventional study, but it did not assess longitudinal adverse events.
Outcome measures
Correlation between AHI and CVHRs
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 09 | Month | 23 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Before follow up
Management information
Registered date
| 2016 | Year | 10 | Month | 04 | Day |
Last modified on
| 2026 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027946
