UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056479 |
|---|---|
| Receipt number | R000064539 |
| Scientific Title | The Relationship Between Sensory Impairments and Sarcopenia in Elderly Patients in Otolaryngology |
| Date of disclosure of the study information | 2024/12/17 |
| Last modified on | 2024/12/17 17:46:39 |
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Basic information
Public title
The Relationship Between Sensory Impairments and Sarcopenia in Elderly Patients in Otolaryngology
Acronym
The Relationship Between Sarcopenia and Sensory Impairments
Scientific Title
The Relationship Between Sensory Impairments and Sarcopenia in Elderly Patients in Otolaryngology
Scientific Title:Acronym
The Relationship Between Sarcopenia and Sensory Impairments
Region
| Japan |
Condition
Condition
Patients Aged 65 and Older with Sensory Impairments in Hearing, Balance, Smell, or Taste
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will measure the Skeletal Muscle Mass Index (SMI) in elderly patients with sensory impairments in hearing, balance, smell, or taste, which can be evaluated and treated in the field of otolaryngology. This research aims to clarify how SMI in elderly individuals with sensory impairments is associated with the duration of illness and the severity of the sensory impairments, and to examine whether the evaluation of sensory impairments can be effective as a screening tool for sarcopenia. Furthermore, by assessing SMI before and after the treatment of sensory impairments, this study aims to determine whether improving sensory impairments can be effective in preventing sarcopenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
<Analysis 1> Comparison Between Severity of Sensory Impairments and SMI
We will evaluate hearing tests, vestibular function tests, olfactory tests, and gustatory tests in relation to SMI for each sensory impairment.
The correlation between test results for each sensory impairment and SMI will be analyzed using Spearman's rank correlation coefficient.
Patients with sensory impairments will be classified into the hearing impairment group, vestibular impairment group, olfactory impairment group, and gustatory impairment group. The SMI obtained in each group will be compared among the four groups using the Steel-Dwass test.
<Analysis 2> Comparison Between Disease Duration of Sensory Impairments and SMI
We will analyze the disease duration obtained through interviews for each sensory impairment in relation to SMI.
The correlation between disease duration and SMI will be analyzed using Spearman's rank correlation coefficient.
<Analysis 3> Comparison of SMI Before and After Treatment of Sensory Impairments
We will compare the SMI at the time of diagnosis of sensory impairments and at the time of improvement or recovery following treatment.
The SMI values before and after treatment will be compared using the Wilcoxon signed-rank test.
Key secondary outcomes
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
Medical procedures exceeding standard care and those performed for research purposes (specifically: standing measurement using a multi-frequency body composition analyzer for approximately 40 seconds).
The diagnosis, evaluation, and treatment of each sensory impairment can be conducted within standard otolaryngology practice. The only additional test performed in this study is the measurement of SMI using a multi-frequency body composition analyzer, which is non-invasive and involves minimal intervention.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Male and female patients aged 65 and older who visited our outpatient clinic with a chief complaint of sensory impairments in hearing, balance, smell, or taste. Patients with sensory impairments that can be evaluated and treated in otolaryngology were selected.
Key exclusion criteria
Patients who have difficulty maintaining a standing position.
Patients with implanted medical electrical devices such as pacemakers.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | FUMIHIRO |
| Middle name | |
| Last name | MOCHIZUKI |
Organization
St. Marianna University School of Medicine Hospital
Division name
Otolaryngology
Zip code
2168511
Address
1-16-2 Sugao, Miyamae-ku ,Kawasaki city ,Kanagawa ,Japan
TEL
+81-44-977-8111
fumihiro0105@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | FUMIHIRO |
| Middle name | |
| Last name | MOCHIZUKI |
Organization
St. Marianna University School of Medicine Hospital
Division name
Otolaryngology
Zip code
2168511
Address
1-16-2 Sugao, Miyamae-ku ,Kawasaki city ,Kanagawa ,Japan
TEL
+81-44-977-8111
Homepage URL
fumihiro0105@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine Institutional Review Board (Clinical Trials Subcommittee)
Address
1-16-2 Sugao, Miyamae-ku ,Kawasaki city ,Kanagawa ,Japan
Tel
+81-44-977-8111
daigakuin@marianna-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
| 2024 | Year | 12 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 12 | Month | 17 | Day |
Last modified on
| 2024 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064539
