UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Junko Katsuta
Organization	National Hospital Organization Iou Hospital
Division name	Nursing Office
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	Chiho Ishida
Organization	National Hospital Organization Iou Hospital
Division name	Clinical Research
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 02 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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