Not Yet RecruitingNot Applicable

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

Spain114 participantsStarted 2026-04

Plain-language summary

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

Who can participate

Age range60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

What they're measuring

Impact on SWS: SO and sleep spindle density

Timeframe: 14 nights

Impact on SWS: SO and sleep spindle duration

Timeframe: 14 nights

Impact on SWS: SO and sleep spindle peak-to-peak amplitude

Timeframe: 14 nights

Impact on SWS: SO and sleep spindle peak power frequency

Timeframe: 14 nights

Impact on SWS: SO and sleep spindle power

Timeframe: 14 nights

Impact on declarative memory consolidation: correct performance in the Verbal Paired Associates test

Timeframe: Up to 3 months after intervention

Impact on procedural memory consolidation: correct performance in the Motor Sequence Typing task

Timeframe: Up to 3 months after intervention

Impact on procedural memory consolidation: incorrect performance in the Motor Sequence Typing task

Timeframe: Up to 3 months after intervention

Trial details

NCT IDNCT07529015

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09

Contact for this trial

Farida Dakterzada, PhD

+34-973702413 farida.dakterzada@udl.cat

View on ClinicalTrials.gov More Alzheimer's Disease (AD) trials

Plain-language summary

Who can participate

Age range60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Impact on SWS: SO and sleep spindle density

Timeframe: 14 nights

Impact on SWS: SO and sleep spindle duration

Timeframe: 14 nights

Impact on SWS: SO and sleep spindle peak-to-peak amplitude

Timeframe: 14 nights

Impact on SWS: SO and sleep spindle peak power frequency

Timeframe: 14 nights

Impact on SWS: SO and sleep spindle power

Timeframe: 14 nights

Impact on declarative memory consolidation: correct performance in the Verbal Paired Associates test

Timeframe: Up to 3 months after intervention

Impact on procedural memory consolidation: correct performance in the Motor Sequence Typing task

Timeframe: Up to 3 months after intervention

Impact on procedural memory consolidation: incorrect performance in the Motor Sequence Typing task

Timeframe: Up to 3 months after intervention