Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061204) titled 'Effect of Intervention Guidance Based on Usage Logs from a Digital Voice Training Application in Older Adults: A Randomized Controlled Trial' on July 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Tokushima University
Condition:
Condition - Presbyphonia
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 50
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 Size - 240
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 01 Day
Anticipated trial start date - 2026 Year 07 Month 01 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070007
Disclaimer: Curated by HT Syndication.
