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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021741
Receipt No. R000024838
Scientific Title Acoustic analysis of swallowing sound for assessment of dysphagia in patients with neuromuscular disorders
Date of disclosure of the study information 2016/05/01
Last modified on 2019/09/30

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Basic information
Public title Acoustic analysis of swallowing sound for assessment of dysphagia in patients with neuromuscular disorders
Acronym Acoustic analysis in patients with neuromuscular disorders
Scientific Title Acoustic analysis of swallowing sound for assessment of dysphagia in patients with neuromuscular disorders
Scientific Title:Acronym Acoustic analysis in patients with neuromuscular disorders
Region
Japan

Condition
Condition Neuromuscular disorders
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy of acoustic analysis of swallowing by auscultation
Basic objectives2 Others
Basic objectives -Others no additional objects
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation of Swallowing contrast imaging and swallowing sound (0M 6M 12M ...)
Key secondary outcomes Clinical outcome measurements including ALSFRS-R, SBMAFRS, and so on.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Videofluoroscopic swallowing study and acoustic analysis of swallowing
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 Patients who meet the diagnostic criteria of neuromuscular diseases (Amyotrophic lateral sclerosis, spinal and bulbar muscular atrophy, et al.)
1) Patients who are 20 years old and over
2) Patients who are able to return to periodic follow-up visit
3) Patiets who gave written informed consent
Key exclusion criteria 1) Patients who have severe complications
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Masahisa
Middle name
Last name Katsuno
Organization Nagoya University Graduate school of Medicine
Division name Department of Neurology
Zip code 4668550
Address Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi
TEL 052-744-2390
Email ka2no@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Atsushi
Middle name
Last name Hashizume
Organization Nagoya University Graduate school of Medicine
Division name Department of Neurology
Zip code 4668550
Address Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi
TEL 052-744-2390
Homepage URL
Email hassy0707@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate school of Medicine
Institute
Department

Funding Source
Organization KAKENHI
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor National Center for geriatrics and gerontology
Aichi Gakuin University, Department of Health Science
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya University hospital ethics committee
Address Tsurumaicho 65, Showa ward, Nagoya city, Aichi prefecture
Tel 052-744-2479
Email ethics@med.nagoya-u.ac.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
2016 Year 05 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 Enrolling by invitation
Date of protocol fixation
2016 Year 03 Month 18 Day
Date of IRB
2019 Year 03 Month 12 Day
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 01 Day
Last modified on
2019 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024838

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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