UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035486 |
|---|---|
| Receipt number | R000040431 |
| Scientific Title | A multicenter study of impact of NIV in the patients with myotonic dystrophy |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2025/01/15 13:18:00 |
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Basic information
Public title
A multicenter study of impact of NIV in the patients with myotonic dystrophy
Acronym
Impact of NIV in the patients with myotonic dystrophy
Scientific Title
A multicenter study of impact of NIV in the patients with myotonic dystrophy
Scientific Title:Acronym
NIVDM
Region
| Japan |
Condition
Condition
myotonic dystrophy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of non-invasive ventilation therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Myotonic Dystrophy Health Index (MDHI)
Key secondary outcomes
SF-36
ESS
FVC
ECG,HolterECG
pulseoxymetry
echocardiogram
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
genetically proven type1 myotonic dystrophy
chronic alveolar hypoventilation
SpO2<94% and/or PaCO2>45Torr
nocturnal desaturation
Key exclusion criteria
severe internistic pre-existing conditions
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kuru |
Organization
Suzuka National Hospital
Division name
Department of neurology
Zip code
5138501
Address
Kasado3-2-1,Suzuka, Mie, Japan
TEL
+81-593-78-1321
kuru.satoshi.rb@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Sadanobu |
| Middle name | |
| Last name | Ito |
Organization
Suzuka National Hospital
Division name
Department of pharmacy
Zip code
5138501
Address
Kasado3-2-1,Suzuka, Mie, Japan
TEL
+81-593-78-1321
Homepage URL
316-research@mail.hosp.go.jp
Sponsor or person
Institute
Suzuka National Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for research and development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka University,Toneyama National hospital,higashisaitama national hospital, Sendai nishitaga national hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suzuka National Hospital
Address
Kasado3-2-1,Suzuka, Mie, Japan
Tel
+81-593-78-1321
miyata.hirotaka.wg@mail.hosp.go.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
| 2019 | 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
| 2018 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The relationship between QOL and compliance with non-invasive ventilation
Management information
Registered date
| 2019 | Year | 01 | Month | 08 | Day |
Last modified on
| 2025 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040431
