听力干预对轻度认知障碍老年人的影响：CHOICE随机临床试验
Hearing Intervention for Older Adults With Mild Cognitive Impairment: The CHOICE Randomized Clinical Trial.
文献信息
| PMID | 42804222 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Ying Chen |
| 作者单位 | Department of Otolaryngology-Head and Neck Surgery, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. |
| 期刊 | JAMA neurology |
| SCI 分区 | Q1 |
| IF | 24 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 耳科 |
中文摘要
重要性： 听力损失是认知衰退的重要可改变危险因素，但听力干预对认知稳定或改善的有效性仍存在争议。
目的： 探讨听力干预能否降低同时存在听力损失和轻度认知障碍（MCI）的老年人中痴呆水平损害的发生率。
设计、场所和参与者： 这项多中心、平行组、开放标签随机临床试验于2021年9月至2024年2月期间进行，24个月随访于2026年2月完成。本研究在中国上海的3家三级耳科门诊和3个CHOICE队列社区卫生站开展。在21908名60岁及以上接受资格评估的成年人中，703名同时患有MCI（临床痴呆评定量表[CDR]全局评分为0.5）和中重度听力损失的参与者被纳入并随机分组。这些数据于2026年2月至2026年7月进行分析。
干预： 参与者按1:1随机接受助听器干预（n=353）或听力保健教育（n=350）。
主要结局和测量指标： 主要结局是24个月内从MCI向痴呆水平损害的转化率，定义为CDR全局评分≥1。关键预设次要结局包括认知改善率（CDR=0）以及CDR全局和领域评分。
结果： 在703名随机分组的患者中（平均[SD]年龄，74.53[7.16]岁；范围，60-96岁；女性250名[35.56%]，男性452名[64.44%]），610名（86.77%）完成了试验。主要结局未观察到显著差异，干预组从MCI向痴呆水平损害的转化率为3.09%（95%CI，1.62%-5.74%），对照组为4.74%（95%CI，2.60%-8.29%）（风险差[RD]，-2.07%；95%CI，-4.74%至0.61%；相对危险度[RR]，0.59；95%CI，0.25-1.38；P=.23）。同时，预设次要分析表明，听力干预提高了认知改善率（15.34%；95%CI，11.84%-19.62% vs 2.36%；95%CI，0.99%-5.22%；RD，12.00%；95%CI，8.79%-15.21%；RR，5.94；95%CI，2.46-14.37）。未报告与研究相关的不良事件。
结论和意义： 在本研究中，对于同时患有轻度认知障碍和听力损失的老年人，助听器干预在24个月时并未显著降低痴呆水平损害的发生率。
试验注册： 中国临床试验注册中心标识符：ChiCTR2000036139。
英文摘要
IMPORTANCE: Hearing loss is a significant modifiable risk factor for cognitive decline, but the effectiveness of hearing intervention for cognition stabilization or improvement still remains controversial.
OBJECTIVE: To investigate whether hearing intervention could reduce dementia-level impairment incidence in older adults with coexisting hearing loss and mild cognitive impairment (MCI).
DESIGN, SETTING, AND PARTICIPANTS: This multicenter, parallel-group, open-label randomized clinical trial was conducted between September 2021 and February 2024, with the 24-month follow-up completed in February 2026. This study was conducted at 3 tertiary otology outpatient clinics and 3 CHOICE cohort community health stations in Shanghai, China. Of 21 908 adults aged 60 years or older assessed for eligibility, 703 participants with coexisting MCI (Clinical Dementia Rating [CDR] global score of 0.5) and moderate to severe hearing loss were enrolled and randomized. These data were analyzed from February 2026 to July 2026.
INTERVENTIONS: Participants were randomized 1:1 to receive either hearing aid intervention (n = 353) or hearing care education (n = 350).
MAIN OUTCOMES AND MEASURES: The primary outcome was the conversion rate from MCI to dementia-level impairment over 24 months, defined as a CDR global score 1 or more. Key prespecified secondary outcomes comprised rate of cognitive improvement (CDR = 0) and CDR global and domain scores.
RESULTS: Among 703 randomized patients (mean [SD] age, 74.53 [7.16] years; range, 60-96 years; 250 female [35.56%] and 452 male [64.44%]), 610 (86.77%) completed the trial. No significant difference was observed in the primary outcome, in which the conversion rate from MCI to dementia-level impairment was 3.09% (95% CI, 1.62%-5.74%) in the intervention group vs 4.74% (95% CI, 2.60%-8.29%) in the control group (risk difference [RD], -2.07%; 95% CI, -4.74% to 0.61%; relative risk [RR], 0.59; 95% CI, 0.25-1.38; P = .23). Meanwhile, prespecified secondary analysis demonstrated that hearing intervention increased the rate of cognitive improvement (15.34%; 95% CI, 11.84%-19.62% vs 2.36%; 95% CI, 0.99%-5.22%; RD, 12.00%; 95% CI, 8.79%-15.21%; RR, 5.94; 95% CI, 2.46-14.37). No study-related adverse events were reported.
CONCLUSIONS AND RELEVANCE: In this study, among older adults with mild cognitive impairment and coexisting hearing loss, a hearing aid intervention did not significantly reduce the incidence of dementia-level impairment at 24 months.
TRIAL REGISTRATION: Chinese Clinical Trial Registry Identifier: ChiCTR2000036139.