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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025731
Receipt No. 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 2018/04/10

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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
Middle name
Last name Kasai Takatoshi
Organization Juntendo University School of Medicine
Division name Department of Cardiovascular Medicine, Cardiovascular Respiratory Sleep Medicine
Zip code
Address 2-1-1 Hongo, Bunkyoku, Tokyo
TEL 03-3813-3111
Email kasai-t@mx6.nisiq.net

Public contact
Name of contact person
1st name
Middle name
Last name Kasai Takatoshi
Organization Juntendo University School of Medicine
Division name Department of Cardiovascular Medicine, Cardiovascular Respiratory Sleep Medicine
Zip code
Address 2-1-1 Hongo, Bunkyoku, Tokyo
TEL 03-3813-3111
Homepage URL
Email kasai-t@mx6.nisiq.net

Sponsor
Institute Juntendo University Hospital
Institute
Department

Funding Source
Organization SomnoMed Japan
Organization
Division
Category of Funding Organization Profit organization
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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2016 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
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
2018 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.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


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