UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025731 |
|---|---|
| Receipt number | R000029600 |
| Scientific Title | Effects of oral appliance (SomnoDent) on sleep disordered breathing (SDB) and cardiac function in patients with heart failure (HF) |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2021/07/25 22:17:34 |
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Basic information
Public title
Effects of oral appliance (SomnoDent) on sleep disordered breathing (SDB) and cardiac function in patients with heart failure (HF)
Acronym
Effects of oral appliance (SomnoDent) on sleep disordered breathing (SDB) and cardiac function in patients with heart failure (HF)
Scientific Title
Effects of oral appliance (SomnoDent) on sleep disordered breathing (SDB) and cardiac function in patients with heart failure (HF)
Scientific Title:Acronym
Effects of oral appliance (SomnoDent) on sleep disordered breathing (SDB) and cardiac function in patients with heart failure (HF)
Region
| Japan |
Condition
Condition
Heart failure (HF)
Sleep disordered breathing (SDB)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether oral appliance (SomnoDent) can effectively suppress SDB in patients with HF, and whether suppression of SDB by oral appliance (SomnoDent) can improve cardiac function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AHI or E/e' by echocardiogram (tissue Doppler image) or plasma BNP level at 3 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
SomnoDent (Intervention)
for 3 months, over 4 hours/day
Interventions/Control_2
Placebo (Control)
for 3 months, over 4 hours/day
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
1) Patients with symptomatic chronic HF (HF diagnosis and on beta blockers over 3 months, No change in HF drugs within 2 weeks)
2) New York Heart Association (NYHA) functional class is greater than or equal to II; either heart failure with reduced ejection fraction (left ventricular ejection fraction is less than or equal to 50%) or heart failure with preserved ejection fraction (history of hospitalization due to acute decompensated heart failure or plasma BNP level is greater than or equal to 100 pg/mL)
3) coexisting SDB (AHI is greater than or equal to 10 and the percentage of central AHI per total AHI is less than or equal to 70%)
Key exclusion criteria
1) Primary valvular heart disease
2) PCI or TAVI or cardiac surgery within 3 months
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takatoshi |
| Middle name | |
| Last name | Kasai |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiovascular Medicine, Cardiovascular Respiratory Sleep Medicine
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyoku, Tokyo
TEL
03-3813-3111
kasai-t@mx6.nisiq.net
Public contact
Name of contact person
| 1st name | Takatoshi |
| Middle name | |
| Last name | Kasai |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiovascular Medicine, Cardiovascular Respiratory Sleep Medicine
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyoku, Tokyo
TEL
03-3813-3111
Homepage URL
kasai-t@mx6.nisiq.net
Sponsor or person
Institute
Juntendo University Hospital
Institute
Department
Personal name
Funding Source
Organization
SomnoMed Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Toranomon Hospital (Devision of Cardiology, Sleep clinic)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospital IRB
Address
2-1-1 Hongo, Bunkyoku, Tokyo
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
| 2017 | Year | 02 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 18 | Day |
Last modified on
| 2021 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029600
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/04/10 | 2. 研究計画書 口腔内装置 (3.3 事務局確認).docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
