Tokyo, Jan. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060042) titled 'Investigation of brain function during speech perception in noise, and changes in brain function associated with auditory rehabilitation' on Jan. 22.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Osaka Metropolitan University

Condition: Condition - Listening Difficulties / Auditory Processing Disorder Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Although previous domestic and international studies have reported on speech understanding at the word or short-phrase level, there have been no studies investigating comprehension of long sentences, as typically encountered in daily life. In the present study, we will examine listening and comprehension, as well as brain function, using sentence-level speech in conditions that approximate real-life listening environments by adding background noise. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Participants will perform home-based auditory training involving sentence listening under noisy conditions. The training will be conducted for a maximum of 10 minutes per day over a period of 30 consecutive days. In principle, participants will be instructed to perform the training once daily, for a total of 30 sessions. If a session cannot be performed due to unavoidable circumstances, the missed session will not be made up.

The training stimuli will consist of sentences (comprising several short phrases) presented under multi-talker babble noise. Each training item will be presented twice. During the first presentation, participants will listen to the audio while visually reading the corresponding text displayed in the video. During the second presentation, participants will listen to the audio while reading the same text aloud.

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1 participants who have provided written informed consent to participate in the study 2 participants who own a device capable of accessing the audio materials such as a smartphone tablet or personal computer or who have access to a device capable of playing CDs

young adults with normal hearing 1 age between 20 and 40 years at the time of consent 2 normal hearing as confirmed by pure tone audiometry four frequency pure tone average pta method B 30 dB or less 3 no subjective symptoms of listening difficulties

older adults with normal hearing 1 age 65 years or older at the time of consent 2 normal hearing as confirmed by pure tone audiometry four frequency pure tone average pta method B 30 dB or less 3 no subjective symptoms of listening difficulties

patients with lid apd 1 age 20 years or older at the time of consent 2 diagnosed with listening difficulties auditory processing disorder lid apd in our department between january 2020 and december 2024 in accordance with the proposed diagnostic criteria described in guidelines for the diagnosis and support of lid apd first edition 2024 amed research outcomes

proposed diagnostic criteria all of the following must be met 1 pure tone audiometry bilateral hearing thresholds less than 25 dB four frequency pta method B 2 speech intelligibility in quiet 85 percent or more 3 presence of subjective listening difficulties defined as

i a score of 109 or less on the questionnaire on listening difficulties developed by Kobuchi et al or ii a score of 6 or more on the checklist for detection of listening difficulties developed by Ogawa et al Key exclusion criteria - 1 individuals who have contraindications to MRI examination or magnetoencephalography including cochlear implants MRI incompatible cardiac pacemakers or claustrophobia 2 individuals who are pregnant or planning to become pregnant at the time of consent 3 individuals with abnormal findings of the external auditory canal or tympanic membrane 4 individuals who are not suitable for MRI imaging or meg measurement including those who have metal in the body such as cardiac pacemakers prosthetic heart valves cochlear or middle ear implants non titanium cerebral aneurysm clips artificial joints orthopedic fixation bolts magnetic dentures implants orthodontic devices tattoos permanent makeup intrauterine devices or metallic foreign bodies in the eyes, and individuals with claustrophobia Target Size - 60

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 02 Month 01 Day Date of IRB - 2025 Year 12 Month 26 Day Anticipated trial start date - 2026 Year 01 Month 22 Day Last follow-up date - 2030 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068515

Disclaimer: Curated by HT Syndication.