NCT07529015Not yet recruiting
Acoustic Stimulation During Sleep: Effects on Memory and p-tau217 in MCI
The Impact of Phase-locked Acoustic Stimulation on Sleep Structure, Memory Consolidation, and Plasma p-tau217 in Patients With Mild Cognitive Impairment
Source: ClinicalTrials.gov · Last updated 14 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 114 (estimated)
- First submitted
- 18 Mar 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Institut de Recerca Biomèdica de Lleida-Fundació Dr. Pifarré (IRBLleida)
- Diseases
- Alzheimer disease
- NCT number
- NCT07529015
What you commit to
- Study type: Interventional
- Planned participants: 114
- From 1 Apr 2026 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Existence of untreated (or treated for less than 3 months prior to the screening visit) vitamin B12 or folate deficiency.
- Use of betablockers, antidepressants, neuroleptics, and hypnotics, within 15 days before conducting polysomnography.
Other illness
- 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.
- Comorbidities such as cancer, severe depression, severe renal or hepatic insufficiency, history of seizures, and severe cardiac or respiratory failure.
- Magnetic resonance imaging (MRI) evidence of stroke, hydrocephalus, a space-occupying lesion, or any clinically relevant central nervous system disease.
- Presence of untreated thyroid disease.
Other
- Hearing problems.
- Analphabet individuals.
- Alcohol and substance abuse.
Who the study is looking for
- 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.
Age in the registry: 60 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Santa Maria de Lleida Coordinator of this site? Confirm its status | Lleida | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.