Development and Validation of an Innovative Gamma Auditory Stimulation System for Older Adults With Cognitive Decline: A Randomized, Double-blind, Placebo-controlled Study (Study 1)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Changes in neurophysiological function.
研究概览
简要总结
Animal studies have shown that 40 Hz auditory stimulation alone can improve spatial memory and reduce Aβ deposition. However, human studies using 40 Hz auditory stimulation alone remain limited. Therefore, this study will use a randomized, double-blind, placebo-controlled design to investigate the effects of 40 Hz auditory stimulation on cognitive function, EEG activity, sleep quality, and quality of life in older adults with mild cognitive impairment (MCI) or mild dementia.
详细描述
Amyloid-beta (Aβ) aggregation and hyperphosphorylated tau protein tangles are widely recognized as the main pathological features of Alzheimer's disease (AD). Numerous domestic and international studies have demonstrated that 40 Hz gamma visual stimulation can effectively enhance 40 Hz gamma neural oscillations in healthy adults and older adults, improve cognitive performance and memory function in older adults and individuals with AD, and has shown good safety with no severe adverse effects.
Nevertheless, there are still several limitations to using 40 Hz visual stimulation as an intervention. Extended exposure to light sources may cause discomfort, affecting participants' willingness to continue. Prolonged light exposure may also increase the risk of seizures in photosensitive individuals. In addition, participants are required to actively fixate on the light source, which may reduce intervention adherence. Most importantly, the ecological validity of light-based stimulation remains low. Many studies require participants to gaze at light for at least five minutes or more, and daily sessions of up to an hour over several months are challenging to implement in daily life. To address these limitations, this project proposes using 40 Hz auditory stimulation as a more practical and sustainable intervention.
Moreover, animal studies have confirmed that 40 Hz auditory stimulation alone can improve spatial memory and reduce Aβ deposition. However, evidence on the independent application of 40 Hz auditory stimulation in humans remains limited. Therefore, this project will adopt a randomized, double-blind, placebo-controlled design to investigate the effects of 40 Hz auditory stimulation on cognitive function, EEG activity, sleep quality, and quality of life in older adults with mild cognitive impairment (MCI) or mild dementia.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 60 years old.
- •CDR scores of 0.5 and 1
- •Voluntary to sign the Informed Consent Form.
排除标准
- •Diagnosis of other psychiatric or neurological disorders
- •Drug or alcohol addictions.
- •Serious heart, liver or kidney disorders, and visual, auditory or motor impairments interfering with neuropsychological tests.
- •History of clinical stroke, major depressive disorder or dysthymic disorder according to the DSM-5.
研究组 & 干预措施
40Hz music group
The 40Hz music is combined with 40Hz sound and music.
干预措施: Gamma auditory stimulation device (active setting) (Device)
Non-40Hz music group
The non-40Hz music is combined with non-40Hz sound and music.
干预措施: Gamma auditory stimulation device (sham setting) (Device)
结局指标
主要结局
Changes in neurophysiological function.
时间窗: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
The changes of power spectral density (PSD), response to gamma auditory stimulation and functional connectivity (FC) at each frequency band will be analyzed by EEG data from each subject.
次要结局
- Change score of the Chinese version Verbal Learning Test (CVVLT).(baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3))
- Change score of the WMS-III logical memory test(baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3))
- Change score of the Taylor Complex Figure Test (TCFT).(baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3))
- Change score of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)(baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3))
- Change score of the Cognitive Abilities Screening Instrument (CASI).(baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3))
- Change score of the category Verbal Fluency Test (VFT).(baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3))
- Performance changes of the Trail Making Test Form A/B (TMT-A/B)(baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3))
- Performance changes of the Digit Span Test(baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3))
- Change score of the neuropsychiatric Inventory (NPI)(baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3))
- Change score of the Geriatric Depression Scale -short form (GDS-S)(baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3))
- Change score of the Pittsburgh Sleep Quality Index (PSQI)(baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3))
- Change score of the 5-level EuroQol-5 Dimension (EQ-5D-5L)(baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3))
- Safety/Adverse events outcome measure(Throughout the three-months intervention)
- Device feasibility outcome measure(Throughout the three-months intervention)
- Change score of the Benson Complex Figure Test.(baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3))
- Change score of the neuropsychiatric Inventory Questionnaire (NPI-Q)(baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3))