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

April 7, 2026 updated by: Farida Dakterzada, Institut de Recerca Biomèdica de Lleida-Fundació Dr. Pifarré (IRBLleida)

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
114

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
    • Catalonia
      • Lleida, Catalonia, Spain, 25198
        • Hospital Universitari Santa Maria de Lleida
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Real-PLAS
Receiving phase-locked acoustic stimulation as an intervention
Device: Plase-Locked Acoustic Stimulation during slow-wave sleep
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
Sham Comparator: Sham-PLAS
Will have the same montage as real-PLAS, but no stimulation will be produced
Device: Phase-locked acoustic stimulation-Sham condition
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
14 nights
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.
14 nights
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.
14 nights
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.
14 nights
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.
14 nights
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.
Up to 3 months after intervention
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.
Up to 3 months after intervention
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.
Up to 3 months after intervention
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.
Up to 3 months after intervention
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.
Up to 3 months after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to 3 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut de Recerca Biomèdica de Lleida-Fundació Dr. Pifarré (IRBLleida)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PI25/01702

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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