Acoustic Stimulation During Sleep: Effects on Memory and p-tau217 in MCI

Starting soon · Not applicable · Has a placebo group

Conditions studied: Alzheimer's Disease (AD), Mild Cognitive Impairment (MCI) Amnestic, Cognitively Unimpaired

In brief

The goal of this clinical trial is to determine whether acoustic stimulation during sleep can enhance slow-wave sleep (SWS), improve cognitive function, and reduce AD-related pathology in individuals with mild cognitive impairment (MCI), compared with cognitively healthy participants. The main questions it aims to answer are: 1. Does acoustic stimulation increase SWS (e.g., slow oscillation and sleep spindle activity) in individuals with MCI? 2. Does enhancing SWS lead to improvements in memory and cognitive performance? 3. Does acoustic stimulation influence plasma p-tau217 levels as a marker of underlying Alzheimer's disease pathology? Researchers will compare participants receiving acoustic stimulation during sleep with those not receiving stimulation to evaluate its effects on sleep architecture, cognition, and plasma biomarkers. Participants will: * Undergo sleep recordings to assess sleep architecture, including SWS, slow oscillations, and sleep spindles * Receive acoustic stimulation during sleep across multiple nights * Complete cognitive assessments, particularly memory-related tasks * Provide blood samples to measure plasma p-tau217 levels * Provide clinical and demographic information for analysis

Key facts

Study ID

NCT07529015

Run by

Institut de Recerca Biomèdica de Lleida-Fundació Dr. Pifarré (IRBLleida)

People needed

114

Starts

2026-04-01

Expected to finish

2028-12-01

Last updated by the study team

2026-04-14

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Diagnosis of aMCI according to the NIA-AA criteria (Albert et al., 2011) and positive state of plasma p-tau217.
• Diagnosis of aMCI according to the NIA-AA criteria (Albert et al., 2011) and negative state of plasma p-tau217 for aMCI negative group.
• Cognitively unimpaired older subjects aged ≥ 65 years, Mini-mental state examination ≥28, and negative for plasma p-tau217.

You may not qualify if…

• Diagnosis of dementia due to AD or any other type of dementia.
• Presence of any diagnosed sleep disorder such as narcolepsy, severe insomnia, severe obstructive sleep apnea, or severe chronic lack of sleep.
• Hearing problems.
• Analphabet individuals.
• Comorbidities such as cancer, severe depression, severe renal or hepatic insufficiency, history of seizures, and severe cardiac or respiratory failure.
• Alcohol and substance abuse.
• Magnetic resonance imaging (MRI) evidence of stroke, hydrocephalus, a space-occupying lesion, or any clinically relevant central nervous system disease.
• Existence of untreated (or treated for less than 3 months prior to the screening visit) vitamin B12 or folate deficiency.
• Presence of untreated thyroid disease.
• Use of betablockers, antidepressants, neuroleptics, and hypnotics, within 15 days before conducting polysomnography.

Where it is running

• Hospital Universitari Santa Maria de Lleida — Lleida, Catalonia, Spain

Full record on ClinicalTrials.gov

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