UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059717 |
|---|---|
| Receipt number | R000068296 |
| Scientific Title | Examination of the Effect of Changes in Acoustic Characteristics Due to Mask Wearing on Speech Intelligibility |
| Date of disclosure of the study information | 2025/11/10 |
| Last modified on | 2025/11/10 10:21:18 |
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Basic information
Public title
Examination of the Effect of Changes in Acoustic Characteristics Due to Mask Wearing on Speech Intelligibility
Acronym
Examination of the Effect of Changes in Acoustic Characteristics Due to Mask Wearing on Speech Intelligibility
Scientific Title
Examination of the Effect of Changes in Acoustic Characteristics Due to Mask Wearing on Speech Intelligibility
Scientific Title:Acronym
Examination of the Effect of Changes in Acoustic Characteristics Due to Mask Wearing on Speech Intelligibility
Region
| Japan |
Condition
Condition
able-bodied person
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective was to analyze speech production in healthy individuals with and without masks, and to investigate the effects of masks on acoustic characteristics and speech intelligibility in an anechoic chamber.
Basic objectives2
Others
Basic objectives -Others
This study serves as a preliminary investigation to explore the characteristics of mask-wearing speech in individuals with neuromuscular disorders. It will be based on an evaluation of the speech characteristics of healthy individuals wearing masks in a noise-free environment, and will lay the groundwork for developing speech training methods and providing advice for conversational situations.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PPQ, APQ, HNR, dB, and velocity (acoustic characteristics) with and without mask
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Wear a mask
Interventions/Control_2
No mask worn
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
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Individuals without a history of otolaryngology consultation regarding voice issues
2) 40 individuals aged 20 to 89 years at the time of examination (20 males, 20 females)
Key exclusion criteria
1) Impaired speech function
2) Lack of capacity to consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Sakamaki |
Organization
National Center of Neurology and Psychiatry Hospital
Division name
Physical Rehabilitation Department
Zip code
187-0032
Address
4-1-1 Ogawa Higashi-cho, Kodaira City, Tokyo
TEL
042-341-2711
sakataku25.b@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Sakamaki |
Organization
National Center of Neurology and Psychiatry Hospital
Division name
Physical Rehabilitation Department
Zip code
187-0032
Address
4-1-1 Ogawa Higashi-cho, Kodaira City, Tokyo
TEL
042-341-2711
Homepage URL
sakataku25.b@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
None
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
National Center of Neurology and Psychiatry Hospital
Address
4-1-1 Ogawa Higashi-cho, Kodaira City, Tokyo
Tel
042-341-2711
sakataku25.b@ncnp.go.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
| 2025 | Year | 11 | Month | 10 | 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
Suspended
Date of protocol fixation
| 2023 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 07 | 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
| 2025 | Year | 11 | Month | 10 | Day |
Last modified on
| 2025 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068296
