Alzheimer's Disease (AD)PAS-MCINCT07529015
Acoustic Stimulation During Sleep: Effects on Memory and p-tau217 in MCI
A study testing Plase-Locked Acoustic Stimulation during slow-wave sleep in people with Alzheimer's Disease (AD) and Mild Cognitive Impairment (MCI) Amnestic, run by Institut de Recerca Biomèdica de Lleida-Fundació Dr. Pifarré (IRBLleida) at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease (AD), Mild Cognitive Impairment (MCI) Amnestic, Cognitively Unimpaired
- What is being tested?
- Plase-Locked Acoustic Stimulation during slow-wave sleep
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gerard Piñol-Ripoll, MD, PhD contact
Spain1 site
Hospital Universitari Santa Maria de Lleida
Lleida, Catalonia, 25198
Cristina Balaguer, +34-937727222 ext. 173, cbalaguer@irblleida.cat
About this study
Official title: 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:
Read more
- Does acoustic stimulation increase SWS (e.g., slow oscillation and sleep spindle activity) in individuals with MCI?
- Does enhancing SWS lead to improvements in memory and cognitive performance?
- 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
- Conditions
- Alzheimer's Disease (AD), Mild Cognitive Impairment (MCI) Amnestic, Cognitively Unimpaired
- Being tested
- Plase-Locked Acoustic Stimulation during slow-wave sleep, Phase-locked acoustic stimulation-Sham condition
- Keywords
- Alzheimer's disease, acoustic stimulation, declarative memory, amnestic mild cognitive impairment, sleep spindle, episodic memory, sleep EEG, slow-wave sleep, p-tau217, slow oscillation
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plase-Locked Acoustic Stimulation during slow-wave sleepDevice
Also called Closed-loop acoustic stimulation, Closed-loop auditive stimulation
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.
Phase-locked acoustic stimulation-Sham conditionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Real-PLAS | Experimental | Receiving phase-locked acoustic stimulation as an intervention Receives: Device: Plase-Locked Acoustic Stimulation during slow-wave sleep |
| Sham-PLAS | Sham comparator | Will have the same montage as real-PLAS, but no stimulation will be produced Receives: Device: Phase-locked acoustic stimulation-Sham condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on SWS: SO and sleep spindle density
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.
Measured: 14 nights
Impact on SWS: SO and sleep spindle duration
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.
Measured: 14 nights
Impact on SWS: SO and sleep spindle peak-to-peak amplitude
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.
Measured: 14 nights
Impact on SWS: SO and sleep spindle peak power frequency
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.
Measured: 14 nights
Impact on SWS: SO and sleep spindle power
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.
Measured: 14 nights
Impact on declarative memory consolidation: correct performance in the Verbal Paired Associates test
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.
Measured: Up to 3 months after intervention
Impact on procedural memory consolidation: correct performance in the Motor Sequence Typing task
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.
Measured: Up to 3 months after intervention
Impact on procedural memory consolidation: incorrect performance in the Motor Sequence Typing task
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.
Measured: Up to 3 months after intervention
Impact on procedural memory consolidation: total attempt performance in the Motor Sequence Typing task
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.
Measured: Up to 3 months after intervention
Impact on p-tau217
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.
Measured: Up to 3 months after intervention
Secondary outcomes (1)
Effect on GFAP and NfL
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.
Measured: Up to 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recerca Biomèdica de Lleida-Fundació Dr. Pifarré (IRBLleida)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farida Dakterzada, Institut de Recerca Biomèdica de Lleida-Fundació Dr. Pifarré (IRBLleida)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529015
- Sponsor's protocol ID
- PI25/01702
- Acronym
- PAS-MCI
- Status last verified
- Apr 2026
- First submitted
- 18 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Phase-locked Acoustic Stimulation on Sleep Structure, Memory Consolidation, and Plasma p-tau217 in Patients With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07529015
- Acronym / sponsor ID
- PAS-MCI / PI25/01702
- Conditions
- Alzheimer's Disease (AD), Mild Cognitive Impairment (MCI) Amnestic, Cognitively Unimpaired
- Keywords
- Alzheimer's disease, acoustic stimulation, declarative memory, amnestic mild cognitive impairment, sleep spindle, episodic memory, sleep EEG, slow-wave sleep
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Institut de Recerca Biomèdica de Lleida-Fundació Dr. Pifarré (IRBLleida)University, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does acoustic stimulation increase SWS (e.g., slow oscillation and sleep spindle activity) in individuals with MCI?
- Does enhancing SWS lead to improvements in memory and cognitive performance?
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-PLAS | Experimental | Device: Plase-Locked Acoustic Stimulation during slow-wave sleepReceiving phase-locked acoustic stimulation as an intervention |
| Sham-PLAS | Sham comparator | Device: Phase-locked acoustic stimulation-Sham conditionWill have the same montage as real-PLAS, but no stimulation will be produced |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plase-Locked Acoustic Stimulation during slow-wave sleepAlso: Closed-loop acoustic stimulation, Closed-loop auditive stimulationParticipants 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. | Device | Real-PLAS |
| Phase-locked acoustic stimulation-Sham conditionParticipants 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. | Device | Sham-PLAS |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
1 secondary outcome
Effect on GFAP and NfL
Time frame: Up to 3 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gerard Piñol-Ripoll, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plase-Locked Acoustic Stimulation during slow-wave sleep in people with Alzheimer's Disease (AD) and Mild Cognitive Impairment (MCI) Amnestic, run by Institut de Recerca Biomèdica de Lleida-Fundació Dr. Pifarré (IRBLleida) at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Farida Dakterzada, PhD (+34-973702413, farida.dakterzada@udl.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on SWS: SO and sleep spindle density (time frame: 14 nights). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.