UMIN-ICDS Clinical Trial

Public title

Effect of Intervention Guidance Based on Usage Logs from a Digital Voice Training Application in Older Adults: A Randomized Controlled Trial

Acronym

Log-Based Voice Training Intervention in Older Adults: RCT

Scientific Title

Effect of Intervention Guidance Based on Usage Logs from a Digital Voice Training Application in Older Adults: A Randomized Controlled Trial

Scientific Title:Acronym

Log-Based Voice Training Intervention in Older Adults: RCT

Region

Japan

Condition

Presbyphonia

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study is to evaluate the effects of intervention modality (digital application vs conventional method) and human support (with vs without) on oral function improvement and training adherence in older adults undergoing voice training.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change in oral diadochokinesis (ODK) from baseline to 3 months

Key secondary outcomes

Changes from baseline to 3 months in the following outcomes:
tongue pressure, oral hygiene status, occlusal force, masticatory performance, oral dryness, swallowing function, lip-seal strength, and Hasegawa Dementia Scale-Revised (HDS-R).
Training adherence (continuation rate) and training activity (frequency, duration, and number of days) will also be assessed.
In addition, associations between app usage logs and improvements in oral function will be explored.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Conventional voice training using paper-based or verbal instructions (e.g., pataka exercises) will be performed for approximately 2 minutes per day.
Training adherence will be self-recorded.
No human support will be provided.

Interventions/Control_2

Participants will perform conventional voice training for approximately 2 minutes per day.
Monthly human support (approximately 10 minutes) will be provided, including feedback and encouragement based on training records.

Interventions/Control_3

Participants will use a smartphone application for daily voice training.
ODK measurement and training will be performed using the application.
Usage data (frequency, duration, and number of days) will be automatically recorded.
No human support will be provided.

Interventions/Control_4

In addition to app-based voice training, participants will receive monthly human support (approximately 10 minutes), including feedback based on app usage logs and encouragement to continue training.

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

50

years-old

<=

Age-upper limit

100

years-old

>

Gender

Male and Female

Key inclusion criteria

Aged 50 years or older
Able to perform vocalization
Able to provide written informed consent

Key exclusion criteria

No access to a smartphone
Unable to use a smartphone application
Severe cognitive impairment (MMSE < 20)
Severe dysphagia
Neuromuscular disease
Marked articulation disorder
Judged inappropriate by the investigator

Target sample size

240

Name of lead principal investigator

1st name	Keiko
Middle name
Last name	Fujimoto

Organization

Tokushima University Graduate School of Biomedical Sciences

Division name

Department of Prosthodontics and Oral Rehabilitation

Zip code

7708504

Address

3-18-15, Kuramoto, Tokushima

TEL

0886337347

Email

fujimoto.keiko@tokushima-u.ac.jp

Name of contact person

1st name	Keiko
Middle name
Last name	Fujimoto

Organization

Tokushima University Graduate School of Biomedical Sciences

Division name

Department of Prosthodontics and Oral Rehabilitation

Zip code

7708504

Address

3-18-15, Kuramoto, Tokushima

TEL

09062808585

Homepage URL

Email

fujimoto.keiko@tokushima-u.ac.jp

Institute

Tokushima University

Institute

Department

Personal name

Keiko Fujimoto

Organization

Tokushima University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Tokushima University Graduate School of Biomedical Sciences

Address

3-18-15, Kuramoto, Tokushima

Tel

0886337347

Email

fujimoto.keiko@tokushima-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

== choose one ==

Institutions

Date of disclosure of the study information

2026

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

07

Month

01

Day

Date of IRB

Anticipated trial start date

2026

Year

07

Month

01

Day

Last follow-up date

2029

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

04

Month

08

Day

Last modified on

2026

Year

04

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070007