Randomized, Double-Blind, Placebo-Controlled Investigation to Validate the Efficacy and Safety of an Auditory Stimulation Treatment During Sleep to Improve Cognitive Abilities Related to Long-Term Memory in Amnestic Mild Cognitive Impairment (aMCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Performance (pre vs post-sleep) in a word pair association task
研究概览
简要总结
This study aims to evaluate the efficacy and safety of Elevvo AudiStim, a sleep auditory stimulation device, as a symptomatic treatment for patients with amnestic mild cognitive impairment (aMCI).
详细描述
Amnestic Mild Cognitive Impairment (aMCI) is a precursor of dementia that involves memory impairment as a primary symptom. The condition presents a valuable opportunity for intervention before a potential progression to more severe, life-altering stages. A technique called "auditory stimulation during sleep" has previously been shown to improve memory by triggering neural oscillations such as slow waves and sleep spindles, which are implicated in memory processing. We hypothesize that the technique might improve memory also in patients with aMCI. This investigation is thus designed to systematically assess both the product's efficacy as a symptomatic treatment for patients with amnestic mild cognitive impairment (aMCI) and its overall safety profile.
After an initial calibration night ("Night 0"), two experimental nights will be performed ("Night 1" and "Night 2"), separated by 14 days. 7 days after each experimental night, a daytime long-term follow-up will be performed ("LT1" and "LT2"). Participants will receive either real or sham auditory stimulation during sleep, such that all participants will participate in both these conditions in a randomized balanced order.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range > 50 years and ≤ 75 years
- •Native Spanish speaker
- •Normal or corrected-to-normal color vision
- •Diagnosis of Alzheimer's disease with an amnestic phenotype at the mild cognitive impairment stage, confirmed according to the current clinical criteria of NIA-AA (2024) and IWG (2024), as well as the clinical protocols of the treating hospital
- •Sufficient hearing without the use of a hearing aid (participant with a hearing threshold of 50 dB or higher in the calibration night hearing test will be excluded)
排除标准
- •Patients with severe and/or complex chronic systemic diseases: Advanced heart disease, Advanced chronic kidney disease, for example, stage 4 or 5, Severe lung disease, such as GOLD stage III-IV COPD, Metastatic or end-stage cancer, Severe hematologic disorders, Active or chronic uncontrolled infectious diseases (e.g., untreated HIV)
- •Evidence of strategic infarcts or other findings on neuroimaging that could be the cause of secondary cognitive impairment
- •Abuse of alcohol or other psychotropic substances
- •Diagnosed for depression or any severe psychiatric disorder in the 5 years prior to the evaluation
- •Changes in treatment with benzodiazepines or antidepressants in the 6 months prior to the initial evaluation
- •Treatment with neuroleptics
- •Epilepsy with active treatment (within the last 5 years) or any comorbidity with a neurological disease that may cause cognitive impairment or brain damage
- •Illiteracy
- •Moderate or severe sleep apnea (without CPAP during the study)
研究组 & 干预措施
Auditory stimulation first
This arm receives auditory stimulation in the first experimental night ("Night 1") and placebo stimulation in the second night ("Night 2").
干预措施: Placebo stimulation (Procedure)
Auditory stimulation first
This arm receives auditory stimulation in the first experimental night ("Night 1") and placebo stimulation in the second night ("Night 2").
干预措施: Auditory Stimulation (Procedure)
Placebo stimulation first
This arm receives placebo stimulation in the first experimental night ("Night 1") and auditory stimulation in the second night ("Night 2").
干预措施: Auditory Stimulation (Procedure)
Placebo stimulation first
This arm receives placebo stimulation in the first experimental night ("Night 1") and auditory stimulation in the second night ("Night 2").
干预措施: Placebo stimulation (Procedure)
结局指标
主要结局
Performance (pre vs post-sleep) in a word pair association task
时间窗: Immediate recall: right before Nights 1/2 (1 hour before going to sleep); Morning recall: right after Nights 1/2 (1 hour after waking up); Long-term recall: during LT 1/2 (7 days after the start day of Nights 1/2).
Memory performance in this task is measured as the number of word pairs recalled during morning and long-term recall, subtracted from the number of word pairs indicated during immediate recall. This metric will be compared between the two experimental conditions.
Performance (pre vs post-sleep) in a visuospatial memory task
时间窗: Immediate recall: right before Nights 1/2 (1 hour before going to sleep); Morning recall: right after Nights 1/2 (1 hour after waking up); Long-term recall: during LT 1/2 (7 days after the start day of Nights 1/2).
Memory performance is measured as the number of recognized images and correctly indicated image locations during morning and long-term recall, subtracted from the respective numbers during immediate recall. This metric will be compared between the two experimental conditions.
次要结局
- Working memory performance(Morning recall: right after Nights 1/2 (1 hour after waking up); Long-term recall: during LT 1/2 (7 days after the start day of Nights 1/2).)
- Slow wave and sleep spindle activity(Throughout Nights 1/2.)
- Sleep macrostructure - Total Sleep Time(Throughout Nights 1/2.)
- Sleep macrostructure - Percentage of Time per Sleep Stage(Throughout Nights 1/2.)
- Sleep macrostructure - Sleep Efficiency(Throughout Nights 1/2.)
- Subjective sleep quality(Administered 0.5-1 hour before and after waking up on Nights 1 and 2.)
- Subjective sleep quality(Administered 15 minutes before sleep onset and 15 minutes after waking up on Nights 1 and 2)