UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023660 |
|---|---|
| Receipt number | R000027254 |
| Scientific Title | Evaluation of respiratory status and examination of effective care for air leak through the mouth during sleep in patients with muscular dystrophy using nasal noninvasive positive-pressure ventilation |
| Date of disclosure of the study information | 2016/08/20 |
| Last modified on | 2016/08/17 20:36:43 |
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Basic information
Public title
Evaluation of respiratory status and examination of effective care for air leak through the mouth during sleep in patients with muscular dystrophy using nasal noninvasive positive-pressure ventilation
Acronym
Nocturnal care for air leak through the mouth in patients with muscular dystrophy using nasal noninvasive positive-pressure ventilation
Scientific Title
Evaluation of respiratory status and examination of effective care for air leak through the mouth during sleep in patients with muscular dystrophy using nasal noninvasive positive-pressure ventilation
Scientific Title:Acronym
Nocturnal care for air leak through the mouth in patients with muscular dystrophy using nasal noninvasive positive-pressure ventilation
Region
| Japan |
Condition
Condition
Duchenne muscular dystrophy
Classification by specialty
| Pneumology | Neurology | Pediatrics |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To diminish the air leak through the mouth during sleep in patients with Duchenne muscular dystrophy using nasal noninvasive positive-pressure ventilation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percutaneous oxygen saturation (SpO2) during sleep
Key secondary outcomes
Percutaneous carbon dioxide pressure (tcPCO2) during sleep
Heart rate during sleep
Sleep scale
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
All the subjects are taken care of with Method A for 10 days followed by Method B for 10 days.
Method A: The mouth and chin are covered with a towel. Then, the face and the towel are fixed with a chinstrap for 8 hours during sleep.
Method B: The mouth and chin are covered with a paper towel folded into twelve, which is made of natural palp and measures 385 by 240 millimeters. Then, the face and the towel are fixed with a chinstrap for 8 hours during sleep.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inpatients with muscular dystrophy using nasal noninvasive positive-pressure ventilation during sleep
Key exclusion criteria
Patients who is judged inadequate to the subjects of this study by the doctor in charge
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junko Katsuta |
Organization
National Hospital Organization Iou Hospital
Division name
Nursing Office
Zip code
Address
Iwade-machi Ni 73-1, Kanazawa, Japan
TEL
+81-76-258-1180
kin11@ioudom.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiho Ishida |
Organization
National Hospital Organization Iou Hospital
Division name
Clinical Research
Zip code
Address
Iwade-machi Ni 73-1, Kanazawa, Japan
TEL
+81-76-258-1180
Homepage URL
cishida@ioudom.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Iou Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Iou Hospital
Organization
Division
Category of Funding Organization
Other
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
独立行政法人国立病院機構医王病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2016 | 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
| 2016 | Year | 08 | Month | 17 | Day |
Last modified on
| 2016 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027254
