UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021741 |
|---|---|
| Receipt number | 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 | 2022/12/20 09:20:35 |
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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
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
hassy0707@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate school of Medicine
Institute
Department
Personal name
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
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
None
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/internalmedicine/56/23/56_8799-16/_article
Number of participants that the trial has enrolled
111
Results
Our results showed that the pharyngeal barium residue after initial swallowing correlated better
with the bulbar-related functional rating scales than that after multiple deglutition. This correlation was vague
when the data from patients whose barium residue was >50% were eliminated. In addition, evaluating the
pharyngeal residue after initial swallowing proved to be the most sensitive method with regard to laryngeal
penetration.
Results date posted
| 2022 | Year | 12 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2017 | Year | 10 | Month | 11 | Day |
Baseline Characteristics
The mean age of the 111 SBMA patients was 53.2 (10.4) years, duration of disease was 11.0 (8.0) years, and age of onset was 42.2 (11.8) years. The ALSFRS-R score at the first visit was 10.6 (1.5).
Participant flow
All patients with SBMA underwent Videofluoroscopic Swallowing Study at Nagoya University Hospital. We also evaluated the patients' background and physical function during the VFSS. None of the subjects had undergone treatment with leuprorelin acetate or other similar drugs at the time of the VFSS.
Adverse events
No adverse events were reported.
Outcome measures
Pharyngeal barium residue and penetration score evaluated by the Videofluoroscopic Swallowing Study (VFSS)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2022 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024838
