NCT06882889 Comparing the Efficacy of Domestic Versus Imported Hearing Aids in ARHL
| NCT ID | NCT06882889 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Condition | Age-related Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-10-24 |
| Primary Completion | 2025-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-10-24 with a primary completion date of 2025-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study compares the hearing improvement effects of domestic hearing aids and imported hearing aids in 80 patients with moderate to severe and severe age-related hearing loss. Patients will be randomly assigned to either the experimental group (domestic hearing aids) or the control group (imported hearing aids) and will undergo a 30-minute trial. Pure Tone Average (PTA) and Speech Recognition Threshold (SRT) will be measured both before and after the trial. The improvements in PTA and SRT will be calculated.The market prices of the hearing aids and the degree of hearing improvement in decibels will be recorded. These data will be used to conduct a comprehensive cost-effectiveness analysis. After the trial, the International Outcome Inventory for Hearing Aids (IOI-HA) and the Abbreviated Profile of Hearing Aid Benefit (APHAB) will be used to assess the benefits of the hearing aids.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 60 years and ≤ 85 years; 2. Diagnosed with age-related hearing Loss, which is characterized by bilateral, symmetrical, and gradually progressive hearing loss primarily affecting high frequencies, along with a decline in speech recognition ability, as referenced in the "Expert Consensus on Diagnosis and Intervention of Age-Related Hearing Loss" (2019 edition); 3. Age-related hearing Loss is of moderate to severe or severe sensorineural hearing loss, with moderate to severe defined as 50 to \<65 dB HL, and severe defined as 65 to \<80 dB HL; 4. Chinese nationality, able to complete all assessments in the Chinese language; 5. Right-handed; 6. No significant neurological diseases, severe systemic diseases, family history of genetic disorders, or major psychiatric conditions; Exclusion Criteria: 1. Exclusion of noise-induced hearing loss, hereditary hearing loss, drug-induced hearing loss, etc.; 2. Inability to use hearing aids ; 3. Presence of dementia, Parkinson's disease, or other neurodegenerative diseases that may affect study compliance; 4. History of cerebrovascular accidents, stroke, epilepsy, or other central nervous system disorders; 5. Other conditions deemed by the investigator to be exclusionary.
Contact & Investigator
Yang Haidi, PhD
STUDY CHAIR
SunYatSunU2H
Frequently Asked Questions
Who can join the NCT06882889 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 85 Years, studying Age-related Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06882889 currently recruiting?
Yes, NCT06882889 is actively recruiting participants. Contact the research team at yanghaidi1978@163.com for enrollment information.
Where is the NCT06882889 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06882889 clinical trial?
NCT06882889 is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. The principal investigator is Yang Haidi, PhD at SunYatSunU2H. The trial plans to enroll 80 participants.