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NCT Number: NCT07529015

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

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

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Key information

Conditions

Alzheimer's Disease (AD) Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitively Unimpaired Dementia Mental Disorders Mild Cognitive Impairment (MCI) Amnestic Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Santa Maria de Lleida

Lleida, Catalonia, 25198, Spain

Location contact

Cristina Balaguer

CONTACT

[email protected]

+34-937727222 ext. 173

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plase-Locked Acoustic Stimulation during slow-wave sleep

Device

Participants will wear a mobile, wearable EEG device during sleep. Sleep will be recorded using EEG, and an algorithm will detect slow oscillations (SOs; >1 Hz). In the real-PLAS arm, acoustic stimulation will be applied in phase with the up-state of these slow oscillations. Specifically, the algorithm will detect each SO and trigger brief pink-noise bursts synchronized with the up-state phase, ensuring phase-locked acoustic stimulation (PLAS) is delivered precisely to enhance slow-wave activity.

Other names: Closed-loop acoustic stimulation, Closed-loop auditive stimulation

Phase-locked acoustic stimulation-Sham condition

Device

Participants will have the same setup as in the real-PLAS arm, wearing a mobile, wearable EEG device during sleep. Sleep will be recorded using EEG, and an algorithm will detect slow oscillations (SOs; >1 Hz). No acoustic stimulation will be applied in the sham-PLAS arm.

Primary outcomes

  1. Impact on SWS: SO and sleep spindle density

    Time frame: 14 nights

    Two defining features of slow-wave sleep (SWS) are slow oscillations (SO) and sleep spindles. Accordingly, the impact of multi-night PLAS on SWS in the study population will be evaluated by measuring the density of both features (expressed as counts per 30 seconds). Post-intervention measurements, including follow-up assessments, will be compared with the baseline night, during which no stimulation is applied, and with the sham group.

  2. Impact on SWS: SO and sleep spindle duration

    Time frame: 14 nights

    Two defining features of slow-wave sleep (SWS) are slow oscillations (SO) and sleep spindles. Accordingly, the impact of multi-night PLAS on SWS in the study population will be evaluated by measuring the duration of both features (expressed in seconds). Post-intervention measurements, including follow-up assessments, will be compared with the baseline night, during which no stimulation is applied, and with the sham group.

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

    Time frame: 14 nights

    Two defining features of slow-wave sleep (SWS) are slow oscillations (SO) and sleep spindles. Accordingly, the impact of multi-night PLAS on SWS in the study population will be evaluated by measuring the peak-to-peak amplitude of both features (expressed in µV).Post-intervention measurements, including follow-up assessments, will be compared with the baseline night, during which no stimulation is applied, and with the sham group.

  4. Impact on SWS: SO and sleep spindle peak power frequency

    Time frame: 14 nights

    Two defining features of slow-wave sleep (SWS) are slow oscillations (SO) and sleep spindles. Accordingly, the impact of multi-night PLAS on SWS in the study population will be evaluated by measuring the peak power frequency of each feature (expressed in Hz). Post-intervention measurements, including follow-up assessments, will be compared with the baseline night, during which no stimulation is applied, and with the sham group.

  5. Impact on SWS: SO and sleep spindle power

    Time frame: 14 nights

    Two defining features of slow-wave sleep (SWS) are slow oscillations (SO) and sleep spindles. Accordingly, the impact of multi-night PLAS on SWS in the study population will be evaluated by measuring the power of both features (expressed in µV2). Post-intervention measurements, including follow-up assessments, will be compared with the baseline night, during which no stimulation is applied, and with the sham group.

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

    Time frame: Up to 3 months after intervention

    The impact of multi-night PLAS on declarative memory performance in the study population will be assessed using the Verbal Paired Associates (VPA) test. Performance will be quantified as the number of correctly recalled word pairs. Post-intervention measurements, including follow-up assessments, will be compared with the first recall, conducted in the morning after the baseline night, and with the sham group.

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

    Time frame: Up to 3 months after intervention

    The impact of multi-night PLAS on procedural memory performance in the study population will be assessed using the Motor Sequence Typing task (MST). Performance will be quantified as the number of correctly executed sequences (i.e., keypresses) per trial. Post-intervention measurements, including follow-up assessments, will be compared with the first recall, conducted in the morning after the baseline night, and with the sham group.

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

    Time frame: Up to 3 months after intervention

    The impact of multi-night PLAS on procedural memory performance in the study population will be assessed using the Motor Sequence Typing task (MST). Performance will be quantified as the number of incorrectly executed sequences (i.e., keypresses) per trial. Post-intervention measurements, including follow-up assessments, will be compared with the first recall, conducted in the morning after the baseline night, and with the sham group.

  9. Impact on procedural memory consolidation: total attempt performance in the Motor Sequence Typing task

    Time frame: Up to 3 months after intervention

    The impact of multi-night PLAS on procedural memory performance in the study population will be assessed using the Motor Sequence Typing Task (MST). Performance will be quantified as the total number of executed sequences (i.e., keypresses) per trial. Post-intervention measurements, including follow-up assessments, will be compared with the first recall, conducted in the morning after the baseline night, and with the sham group.

  10. Impact on p-tau217

    Time frame: Up to 3 months after intervention

    Post-intervention plasma levels of p-tau217(pg/mL), including follow-up assessments, will be measured in the study population and compared with baseline values as well as with the sham group.

Secondary outcomes

  1. Effect on GFAP and NfL

    Time frame: Up to 3 months after intervention

    Post-intervention plasma levels of Glial fibrillary acidic protein (GFAP, pg/mL) and neurofilament light (NfL, pg/mL), including follow-up assessments, will be measured in the study population and compared with baseline values as well as with the sham group.

Study contacts

Contact information is provided by the study sponsor or research team.

Farida Dakterzada, PhD

CONTACT

[email protected]

+34-973702413

Gerard Piñol-Ripoll, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

The Impact of Phase-locked Acoustic Stimulation on Sleep Structure, Memory Consolidation, and Plasma p-tau217 in Patients With Mild Cognitive Impairment

Acronym: PAS-MCI

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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