UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031166 |
|---|---|
| Receipt number | 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 | 2022/08/20 12:52:44 |
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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
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
ash@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Chiba Hokusoh Hospital
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 01 | Day |
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
| 2022 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035250
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
