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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023660
Receipt No. 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

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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
Email 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
Email cishida@ioudom.hosp.go.jp

Sponsor
Institute National Hospital Organization Iou Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027254

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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