A Non-Inferiority, Single-Blind, Randomized Controlled Trial Comparing the Efficacy of Domestic Versus Imported Hearing Aids in Patients With Moderate to Severe and Severe Age-Related Hearing Loss
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Improvement in Pure Tone Average (ΔPTA)
研究概览
简要总结
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.
详细描述
This study aims to conduct a non-inferiority, single-blind, randomized controlled trial to compare the hearing improvement effects of domestic hearing aids versus imported hearing aids in patients with moderate to severe and severe age-related hearing loss.
A total of 80 patients meeting the inclusion and exclusion criteria will be randomly assigned to either the experimental group (domestic hearing aids) or the control group (imported hearing aids).
The domestic hearing aids used in this study are from the Bigsound brand and include behind-the-ear (BTE), neck-worn, and in-the-ear (ITE) styles. All of these hearing aids are rechargeable.The imported hearing aids used in this study are from the Phonak brand and include behind-the-ear (BTE), neck-worn, and in-the-ear (ITE) styles.
Each group will undergo a 30-minute trial with their respective hearing aids. Pure Tone Average (PTA) and Speech Recognition Threshold (SRT) before and after the 30-minute trial will be collected, and the improvements in PTA and SRT will be calculated.The market price of the hearing aids and the degree of hearing improvement in decibels for each patient will be recorded, and a comprehensive cost-effectiveness analysis will be performed. Additionally, after the 30-minute 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.
Statistical analyses will be conducted to determine whether the domestic hearing aids are non-inferior to the imported hearing aids in terms of hearing and speech improvement. The analysis will also evaluate patient satisfaction, performance in different listening environments, and adaptation to the hearing aids for both the domestic hearing aids and imported hearing aids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years and ≤ 85 years;
- •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);
- •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;
- •Chinese nationality, able to complete all assessments in the Chinese language;
- •Right-handed;
- •No significant neurological diseases, severe systemic diseases, family history of genetic disorders, or major psychiatric conditions;
排除标准
- •Exclusion of noise-induced hearing loss, hereditary hearing loss, drug-induced hearing loss, etc.;
- •Inability to use hearing aids ;
- •Presence of dementia, Parkinson's disease, or other neurodegenerative diseases that may affect study compliance;
- •History of cerebrovascular accidents, stroke, epilepsy, or other central nervous system disorders;
- •Other conditions deemed by the investigator to be exclusionary.
研究组 & 干预措施
The experimental group
The experimental group will use domestic hearing aids.
干预措施: Domestic hearing aids (Device)
The control group
The control group will use imported hearing aids.
干预措施: Imported hearing aids (Device)
结局指标
主要结局
Improvement in Pure Tone Average (ΔPTA)
时间窗: The initial assessment will be conducted prior to the use of the hearing aid, and the follow-up assessment will be performed 0.5 hours after the hearing aid is used.
Improvement in Pure Tone Average (ΔPTA): The improvement in Pure Tone Average (ΔPTA) will be assessed by measuring the average of the lowest sound intensities detectable at 0.5 kHz, 1 kHz, 2 kHz, and 4 kHz in the better ear of patients with moderate to severe and severe age-related hearing loss both before and after hearing aid fitting, using pure tone audiometry and sound field audiometry. These measurements will be recorded as pre-fitting PTA and post-fitting PTA. Improvement in Pure Tone Average (ΔPTA) = post-fitting PTA - pre-fitting PTA
次要结局
- International Outcome Inventory for Hearing Aids (IOI-HA)(The assessment will be conducted only after the patient has used the hearing aid for 0.5 hours.)
- Abbreviated Profile of Hearing Aid Benefit (APHAB)(The assessment will be conducted only after the patient has used the hearing aid for 0.5 hours.)
- Cost-Effectiveness Analysis (CEA):(The assessment will be conducted only after the patient has used the hearing aid for 0.5 hours.)
- Improvement in Speech Recognition Threshold (ΔSRT)(The initial assessment will be conducted prior to the use of the hearing aid, and the follow-up assessment will be performed 0.5 hours after the hearing aid is used.)