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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031166
Receipt No. R000035250
Scientific Title Impact of Nocturnal Head Positioning on Sleep Apnea in Patients with Heart Failure: a Randomized Trial
Date of disclosure of the study information 2018/03/01
Last modified on 2018/02/06

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Basic information
Public title Impact of Nocturnal Head Positioning on Sleep Apnea in Patients with Heart Failure: a Randomized Trial
Acronym INCENT-HF Trial
Scientific Title Impact of Nocturnal Head Positioning on Sleep Apnea in Patients with Heart Failure: a Randomized Trial
Scientific Title:Acronym INCENT-HF Trial
Region
Japan

Condition
Condition Heart failure with sleep apnea
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the present study is to examine whether a nocturnal semirecumbent position with head-up to 30 degrees inproves the severity of sleep apnea in patients with heart failure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Apnea-hypopnea index while subjects is sleeping in a semirecumbent position with head-up to 30 degrees.
Key secondary outcomes Values of high-sensitivity troponin T and N-terminal pro-B-type natriuretic peptide in the morning.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Subjects sleeping in a semirecumbent position with head-up to 30 degrees.
Interventions/Control_2 Subjects sleeping with a bed flat.
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
85 years-old >=
Gender Male
Key inclusion criteria 1. Heart failure patients with sleep apnea and AHI more than and equal to 20.
2. Left ventricular ejection fraction less than 45%.
Key exclusion criteria 1. Patients complicated with severe COPD.
2. Patients underwent myocardial infarction and coronary artery bypass surgery within three months.
3. Patients with permanent pacemaker or implantable defibrillator.
Target sample size 145

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ayaka Shima
Organization Nippon Medical School Chiba Hokusoh Hospital
Division name Cardiovascular Center
Zip code
Address 1715 Kamagari, Inzai, Chiba, JAPAN
TEL 0476-99-1111
Email ash@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayaka Shima
Organization Nippon Medical School Chiba Hokusoh Hospital
Division name Cardiovascular Center
Zip code
Address 1715 Kamagari, Inzai, Chiba, JAPAN
TEL 0476-99-1111
Homepage URL
Email ash@nms.ac.jp

Sponsor
Institute Nippon Medical School Chiba Hokusoh Hospital
Institute
Department

Funding Source
Organization Nippon Medical School Chiba Hokusoh Hospital
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
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 日本医科大学千葉北総病院(千葉県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 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 Preinitiation
Date of protocol fixation
2018 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
2019 Year 09 Month 30 Day
Date trial data considered complete
2019 Year 11 Month 30 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 02 Month 06 Day
Last modified on
2018 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035250

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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